A D Co L T D

FDA Filings

This page includes the latest FDA filings for A D Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

JAPAN

TOKYO STOCK EXCHANGE

7745

DUNS 691722987

FDA Registration(s)

• Registration Number: 2082313
• FEI Number: 2082313
• Name: A&D ENGINEERING, INC.
• Owner & Operator: A&D Company, Limited
• Contact Address: 3-23-14 HIGASHI-IKEBUKURO DAIHATSU-NISSAY IKEBUKURO; BLDG. 5-F, TOSHIMA-KU, TOKYO JP-NOTA 170-0013 JP
• Official Correspondent:
  • Jerry - Wang
  • 81-03-53916126-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 1756 AUTOMATION PARKWAY ; SAN JOSE, CA 95131 US
• Establishment Type:
  • Complaint File Establishment per 21 CFR 820.198
  • Repack or Relabel Medical Device

• Registration Number: 3006899423
• FEI Number: 3006899423
• Name: Jerry Wang
• Owner & Operator: A&D Company, Limited
• Contact Address: 3-23-14 HIGASHI-IKEBUKURO DAIHATSU-NISSAY IKEBUKURO; BLDG. 5-F, TOSHIMA-KU, TOKYO JP-NOTA 170-0013 JP
• Official Correspondent:
  • Jerry - Wang
  • 81-03-53916126-x
• US Agent:
  • Jerry Wang
  • A&D Engineering, Inc.
  • 408 3343326
  • jwang@andonline.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1756 Automation Parkway ; San Jose, CA 95131 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

• Registration Number: 3012935929
• FEI Number: 3012935929
• Name: Jerry Wang
• Owner & Operator: A&D Company, Limited
• Contact Address: 3-23-14 HIGASHI-IKEBUKURO DAIHATSU-NISSAY IKEBUKURO; BLDG. 5-F, TOSHIMA-KU, TOKYO JP-NOTA 170-0013 JP
• Official Correspondent:
  • Jerry - Wang
  • 81-03-53916126-x
• US Agent:
  • Jerry Wang
  • A&D Engineering, Inc.
  • 408 3343326
  • jwang@andonline.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1756 Automation Parkway ; San Jose, CA 95131 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

• Registration Number: 3003864328
• FEI Number: 3003864328
• Name: A&D Company, Limited - Tech Center
• Owner & Operator: A&D Company, Limited
• Contact Address: 3-23-14 HIGASHI-IKEBUKURO DAIHATSU-NISSAY IKEBUKURO; BLDG. 5-F, TOSHIMA-KU, TOKYO JP-NOTA 170-0013 JP
• Official Correspondent:
  • Jerry - Wang
  • 81-03-53916126-x
• US Agent:
  • Jerry Wang
  • A&D Engineering, Inc.
  • 408 3343326
  • 408 6352313
  • jwang@andonline.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1-243 Asahi ; Kitamoto-shi Saitama, 364-8585 JP
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Complaint File Establishment per 21 CFR 820.198

• Registration Number: 3013920399
• FEI Number: 3013920399
• Name: A&D Vietnam Limited
• Owner & Operator: A&D Company, Limited
• Contact Address: 3-23-14 HIGASHI-IKEBUKURO DAIHATSU-NISSAY IKEBUKURO; BLDG. 5-F, TOSHIMA-KU, TOKYO JP-NOTA 170-0013 JP
• Official Correspondent:
  • Jerry - Wang
  • 81-03-53916126-x
• US Agent:
  • Jerry Wang
  • A&D Engineering, Inc.
  • 408 3343326
  • jwang@andonline.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: No. 28, Street 5, Integrated Township and Industrial Park VSIP B ; Tu Son Town Bac Ninh, ---- VN
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

• Registration Number: 3004128050
• FEI Number: 3004128050
• Name: Jerry Wang
• Owner & Operator: A&D Company, Limited
• Contact Address: 3-23-14 HIGASHI-IKEBUKURO DAIHATSU-NISSAY IKEBUKURO; BLDG. 5-F, TOSHIMA-KU, TOKYO JP-NOTA 170-0013 JP
• Official Correspondent:
  • Jerry - Wang
  • 81-03-53916126-x
• US Agent:
  • Jerry Wang
  • A&D ENGINEERING, INC.
  • 408 2635333
  • 408 6352313
  • jwang@ANDONLINE.COM
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1756 Automation Parkway ; San Jose, CA 95131 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

• Registration Number: 1054421
• FEI Number: 1000110823
• Name: A&D Engineering, Inc.
• Owner & Operator: A&D Company, Limited
• Contact Address: 3-23-14 HIGASHI-IKEBUKURO DAIHATSU-NISSAY IKEBUKURO; BLDG. 5-F, TOSHIMA-KU, TOKYO JP-NOTA 170-0013 JP
• Official Correspondent:
  • Jerry - Wang
  • 81-03-53916126-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 2605 N.Berkeley Lake Rd. Bldg 100, ste 350; Duluth, GA 30096 US
• Establishment Type:
  • Repack or Relabel Medical Device
  • Complaint File Establishment per 21 CFR 820.198

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
GUDID 00093764604546 A&D COMPANY, LIMITED	A&D Medical UC-356BLE-ST	2024-10-28
GUDID 00093764604140 A&D COMPANY, LIMITED	A&D Medical UC-356BLE	2024-10-28
GUDID 00093764604454 A&D COMPANY, LIMITED	A&D Medical UC-352CEL	2024-10-24
GUDID 00093764604515 A&D COMPANY, LIMITED	A&D Medical UA-1040TBLE	2024-09-09
GUDID 00093764604508 A&D COMPANY, LIMITED	A&D Medical UA-770BLE	2024-09-09
GUDID 00093764604492 A&D COMPANY, LIMITED	A&D Medical UA-660	2024-09-09
GUDID 00093764604133 A&D COMPANY, LIMITED	A&D Medical UP-200	2024-02-23
GUDID 00093764604461 A&D COMPANY, LIMITED	A&D Medical UC-450BLE-CV	2024-01-09
GUDID 00093764604393 A&D COMPANY, LIMITED	A&D Medical UA-651S-AC	2023-07-10
PMN K212168 A&D Company, Ltd	A&D Medical UM-212BLE Blood Pressure Monitor	2022-10-06
GUDID 00093764604256 A&D COMPANY, LIMITED	A&D Medical UA-651CEL-SM	2022-07-08
GUDID 05060006581335 A&D COMPANY, LIMITED	A&D Medical UM-211	2021-07-27
GUDID 00093764603976 A&D COMPANY, LIMITED	A&D Medical UB-525	2020-07-08
FRI Jerry Wang [A&D Company, Limited]	UC-355PBT-Ci	2020-02-03
FRI Jerry Wang [A&D Company, Limited]	UC-355PBT-Ci	2020-02-03
FRI Jerry Wang [A&D Company, Limited]	UC-352BLE	2020-02-03
FRI Jerry Wang [A&D Company, Limited]	UC-352BLE	2020-02-03
FRI Jerry Wang [A&D Company, Limited]	UC-352BLE-V	2020-02-03
FRI Jerry Wang [A&D Company, Limited]	UC-352BLE-V	2020-02-03
FRI Jerry Wang [A&D Company, Limited]	UC-351PBT-Ci	2020-02-03
FRI Jerry Wang [A&D Company, Limited]	UC-351PBT-Ci	2020-02-03
FRI Jerry Wang [A&D Company, Limited]	UC-351	2020-02-03
FRI Jerry Wang [A&D Company, Limited]	UC-351	2020-02-03
FRI Jerry Wang [A&D Company, Limited]	UC-350BLE	2020-02-03
FRI Jerry Wang [A&D Company, Limited]	UC-350BLE	2020-02-03
FRI Jerry Wang [A&D Company, Limited]	UC-321PBT-Q	2020-02-03
FRI Jerry Wang [A&D Company, Limited]	UC-321PBT-Q	2020-02-03
FRI A&D Engineering, Inc. [A&D Company, Limited]	UC-355PBT-Ci	2020-02-03
FRI A&D Engineering, Inc. [A&D Company, Limited]	UC-352BLE	2020-02-03
FRI A&D Engineering, Inc. [A&D Company, Limited]	UC-352BLE-V	2020-02-03
FRI A&D Engineering, Inc. [A&D Company, Limited]	UC-351PBT-Ci	2020-02-03
FRI A&D Engineering, Inc. [A&D Company, Limited]	UC-351	2020-02-03
FRI A&D Engineering, Inc. [A&D Company, Limited]	UC-350BLE	2020-02-03
FRI A&D Engineering, Inc. [A&D Company, Limited]	UC-321PBT-Q	2020-02-03
FRI A&D ENGINEERING, INC. [A&D Company, Limited]	UC-355PBT-Ci	2020-02-03
FRI A&D ENGINEERING, INC. [A&D Company, Limited]	UC-352BLE	2020-02-03
FRI A&D ENGINEERING, INC. [A&D Company, Limited]	UC-352BLE-V	2020-02-03
FRI A&D ENGINEERING, INC. [A&D Company, Limited]	UC-351PBT-Ci	2020-02-03
FRI A&D ENGINEERING, INC. [A&D Company, Limited]	UC-351	2020-02-03
FRI A&D ENGINEERING, INC. [A&D Company, Limited]	UC-350BLE	2020-02-03
FRI A&D ENGINEERING, INC. [A&D Company, Limited]	UC-321PBT-Q	2020-02-03
FRI A&D Company, Limited - Tech Center [A&D Company, Limited]	UC-355PBT-Ci	2020-02-03
FRI A&D Company, Limited - Tech Center [A&D Company, Limited]	UC-352BLE	2020-02-03
FRI A&D Company, Limited - Tech Center [A&D Company, Limited]	UC-352BLE-V	2020-02-03
FRI A&D Company, Limited - Tech Center [A&D Company, Limited]	UC-351PBT-Ci	2020-02-03
FRI A&D Company, Limited - Tech Center [A&D Company, Limited]	UC-351	2020-02-03
FRI A&D Company, Limited - Tech Center [A&D Company, Limited]	UC-350BLE	2020-02-03
FRI A&D Company, Limited - Tech Center [A&D Company, Limited]	UC-321PBT-Q	2020-02-03
GUDID 00093764603754 A&D COMPANY, LIMITED	A&D Medical UA-1200CNBLE	2019-12-02
GUDID 00802526553257 A&D COMPANY, LIMITED	A&D Medical UA-767PBT-Q	2019-11-08
GUDID 00802526476990 A&D COMPANY, LIMITED	A&D Medical UA-767PBT-Q	2019-11-08
GUDID 00093764603938 A&D COMPANY, LIMITED	A&D Medical UM-211	2019-11-08
GUDID 00093764603921 A&D COMPANY, LIMITED	A&D Medical TM-2441	2019-11-08
GUDID 00093764603914 A&D COMPANY, LIMITED	A&D Medical TM-2440	2019-11-08
GUDID 00093764603877 A&D COMPANY, LIMITED	A&D Medical UA-651BLE-HH	2019-11-08
GUDID 00093764603822 A&D COMPANY, LIMITED	A&D Medical UA-651W-AC	2019-11-08
GUDID 00093764603792 A&D COMPANY, LIMITED	A&D Medical TM-2430	2019-11-08
GUDID 00093764603785 A&D COMPANY, LIMITED	A&D Medical UA-651BLES-V	2019-11-08
GUDID 00093764603747 A&D COMPANY, LIMITED	A&D Medical UA-767PBTS-CiV	2019-11-08
GUDID 00093764603709 A&D COMPANY, LIMITED	A&D Medical UB-1100BLE	2019-11-08
GUDID 00093764603693 A&D COMPANY, LIMITED	A&D Medical UA-1200BLE	2019-11-08
GUDID 00093764603686 A&D COMPANY, LIMITED	A&D Medical UA-767PBT-CiV & UA-767PBTL-CiV	2019-11-08
GUDID 00093764603679 A&D COMPANY, LIMITED	A&D Medical UA-767PBT-Ci, UA-767PBT-Ci for small cuff	2019-11-08
GUDID 00093764603624 A&D COMPANY, LIMITED	A&D Medical UA-651W-V	2019-11-08
GUDID 00093764603587 A&D COMPANY, LIMITED	A&D Medical UA-651L-AC	2019-11-08
GUDID 00093764603570 A&D COMPANY, LIMITED	A&D Medical UA-651M-AC	2019-11-08
GUDID 00093764603563 A&D COMPANY, LIMITED	A&D Medical UA-651S-AC	2019-11-08
GUDID 00093764603556 A&D COMPANY, LIMITED	A&D Medical UA-651BLE-V, UA-651BLE-HH2	2019-11-08
GUDID 00093764603501 A&D COMPANY, LIMITED	A&D Medical TM-2657P, TM-2657P-RS, TM-2657P-BT	2019-11-08
GUDID 00093764603464 A&D COMPANY, LIMITED	A&D Medical UA-651L-V	2019-11-08
GUDID 00093764603457 A&D COMPANY, LIMITED	A&D Medical UA-651M-V	2019-11-08
GUDID 00093764603440 A&D COMPANY, LIMITED	A&D Medical UA-651S-V	2019-11-08
GUDID 00093764603372 A&D COMPANY, LIMITED	A&D Medical UA-767FAC	2019-11-08
GUDID 00093764603365 A&D COMPANY, LIMITED	A&D Medical UA-767F	2019-11-08
GUDID 00093764603358 A&D COMPANY, LIMITED	A&D Medical UB-543	2019-11-08
GUDID 00093764603341 A&D COMPANY, LIMITED	A&D Medical UA-651	2019-11-08
GUDID 00093764603327 A&D COMPANY, LIMITED	A&D Medical UA-651BLE	2019-11-08
GUDID 00093764603174 A&D COMPANY, LIMITED	A&D Medical UA-611	2019-11-08
GUDID 00093764603013 A&D COMPANY, LIMITED	A&D Medical UB-351B	2019-11-08
GUDID 00093764602931 A&D COMPANY, LIMITED	A&D Medical UA-1030T	2019-11-08
GUDID 00093764602870 A&D COMPANY, LIMITED	A&D Medical UA-1020	2019-11-08
GUDID 00093764602399 A&D COMPANY, LIMITED	A&D Medical UA-767PVSA	2019-11-08
GUDID 00093764602382 A&D COMPANY, LIMITED	A&D Medical UA-767PVLA	2019-11-08
GUDID 00093764602375 A&D COMPANY, LIMITED	A&D Medical UA-767PVA	2019-11-08
GUDID 00093764602139 A&D COMPANY, LIMITED	A&D Medical UB-521	2019-11-08
GUDID 00093764602016 A&D COMPANY, LIMITED	A&D Medical UA-851VL	2019-11-08
GUDID 00093764602009 A&D COMPANY, LIMITED	A&D Medical UA-851V	2019-11-08
GUDID 00093764601583 A&D COMPANY, LIMITED	A&D Medical UA-705VL	2019-11-08
GUDID 00093764601576 A&D COMPANY, LIMITED	A&D Medical UA-705V	2019-11-08
GUDID 00093764601552 A&D COMPANY, LIMITED	A&D Medical UA-787EJ	2019-11-08
GUDID 00093764601538 A&D COMPANY, LIMITED	A&D Medical UB-512	2019-11-08
GUDID 00093764600623 A&D COMPANY, LIMITED	A&D Medical UA-789AC	2019-11-08
GUDID 00093764600562 A&D COMPANY, LIMITED	A&D Medical UA-767PVS	2019-11-08
PMN K163518 | FLL A&D Engineering, Inc. [A&D Company, Limited]	DT-105 Thermometer	2019-10-02
PMN K163518 | FLL A&D ENGINEERING, INC. [A&D Company, Limited]	DT-105 Thermometer	2019-10-02
PMN K173065 | DXN Jerry Wang [A&D Company, Limited]	TM-2440 & TM-2441	2019-06-19
PMN K173065 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	TM-2440 & TM-2441	2019-06-19
PMN K173065 A&D Company, Ltd	A&D Medical Blood Pressure Monitors	2019-04-24
PMN K173191 | DXN Jerry Wang [A&D Company, Limited]	A&D Medical UM-211 Digital Blood Pressure Monitor	2019-03-27
PMN K173191 | DXN A&D Engineering, Inc. [A&D Company, Limited]	A&D Medical UM-211 Digital Blood Pressure Monitor	2019-03-27
PMN K173191 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	A&D Medical UM-211 Digital Blood Pressure Monitor	2019-03-27
PMN K173191 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	A&D Medical UM-211 Digital Blood Pressure Monitor	2019-03-27
PMN K173191 A&D Company, Ltd.	A&D Medical Blood Pressure Monitors	2019-03-21
PMN K170196 | DXN Jerry Wang [A&D Company, Limited]	UltraConnect UB-1100BLE Blood Pressure Monitor	2017-08-11
PMN K170196 | DXN A&D Engineering, Inc. [A&D Company, Limited]	UltraConnect UB-1100BLE Blood Pressure Monitor	2017-08-11
PMN K170196 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	UltraConnect UB-1100BLE Blood Pressure Monitor	2017-08-11
PMN K170196 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	UltraConnect UB-1100BLE Blood Pressure Monitor	2017-08-11
PMN K163683 | DXN Jerry Wang [A&D Company, Limited]	UltraConnect UA-1200BLE Blood Pressure Monitor	2017-08-11
PMN K163683 | DXN A&D Engineering, Inc. [A&D Company, Limited]	UltraConnect UA-1200BLE Blood Pressure Monitor	2017-08-11
PMN K163683 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	UltraConnect UA-1200BLE Blood Pressure Monitor	2017-08-11
PMN K163683 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	UltraConnect UA-1200BLE Blood Pressure Monitor	2017-08-11
PMN K170196 A&D Company, Ltd.	A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor	2017-05-17
PMN K163683 A&D COMPANY, LTD	A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor	2017-05-03
PMN K141179 | DXN Jerry Wang [A&D Company, Limited]	A&D Medical UB-543	2016-01-26
PMN K141179 | DXN A&D Engineering, Inc. [A&D Company, Limited]	A&D Medical UB-543	2016-01-26
PMN K141179 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	A&D Medical UB-543	2016-01-26
PMN K141179 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	A&D Medical UB-543	2016-01-26
PMN K141201 | DXN Jerry Wang [A&D Company, Limited]	UA-767FAC	2014-10-21
PMN K141201 | DXN Jerry Wang [A&D Company, Limited]	UA-767F	2014-10-21
PMN K141201 | DXN A&D Vietnam Limited [A&D Company, Limited]	UA-767FAC	2014-10-21
PMN K141201 | DXN A&D Vietnam Limited [A&D Company, Limited]	UA-767F	2014-10-21
PMN K141201 | DXN A&D Engineering, Inc. [A&D Company, Limited]	UA-767FAC	2014-10-21
PMN K141201 | DXN A&D Engineering, Inc. [A&D Company, Limited]	UA-767F	2014-10-21
PMN K141201 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	UA-767FAC	2014-10-21
PMN K141201 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	UA-767F	2014-10-21
PMN K141201 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	UA-767FAC	2014-10-21
PMN K141201 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	UA-767F	2014-10-21
PMN K141160 | DXN Jerry Wang [A&D Company, Limited]	UA-651	2014-10-21
PMN K141160 | DXN Jerry Wang [A&D Company, Limited]	UA-651	2014-10-21
PMN K141160 | DXN A&D Engineering, Inc. [A&D Company, Limited]	UA-651	2014-10-21
PMN K141160 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	UA-651	2014-10-21
PMN K141160 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	UA-651	2014-10-21
PMN K032499 | DXN Jerry Wang [A&D Company, Limited]	UA-705	2014-06-02
PMN K032499 | DXN Jerry Wang [A&D Company, Limited]	UA-704	2014-06-02
PMN K032499 | DXN Jerry Wang [A&D Company, Limited]	System, Measurement, Blood Pressure Non-invasive	2014-06-02
PMN K032499 | DXN A&D Engineering, Inc. [A&D Company, Limited]	UA-705	2014-06-02
PMN K032499 | DXN A&D Engineering, Inc. [A&D Company, Limited]	UA-704	2014-06-02
PMN K032499 | DXN A&D Engineering, Inc. [A&D Company, Limited]	System, Measurement, Blood Pressure Non-invasive	2014-06-02
PMN K032499 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	UA-705	2014-06-02
PMN K032499 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	UA-704	2014-06-02
PMN K032499 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	System, Measurement, Blood Pressure Non-invasive	2014-06-02
PMN K032499 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	UA-705	2014-06-02
PMN K032499 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	UA-704	2014-06-02
PMN K032499 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	System, Measurement, Blood Pressure Non-invasive	2014-06-02
PMN K012472 | DXN Jerry Wang [A&D Company, Limited]	UA-853LAC	2014-05-29
PMN K012472 | DXN Jerry Wang [A&D Company, Limited]	UA-853AC	2014-05-29
PMN K012472 | DXN Jerry Wang [A&D Company, Limited]	UA-851VL	2014-05-29
PMN K012472 | DXN Jerry Wang [A&D Company, Limited]	UA-851V	2014-05-29
PMN K012472 | DXN Jerry Wang [A&D Company, Limited]	UA-787EJ	2014-05-29
PMN K012472 | DXN Jerry Wang [A&D Company, Limited]	UA-774AC	2014-05-29
PMN K012472 | DXN Jerry Wang [A&D Company, Limited]	UA-767Plus	2014-05-29
PMN K012472 | DXN Jerry Wang [A&D Company, Limited]	UA-767PVS	2014-05-29
PMN K012472 | DXN Jerry Wang [A&D Company, Limited]	UA-767PVL	2014-05-29
PMN K012472 | DXN Jerry Wang [A&D Company, Limited]	UA-767PV	2014-05-29
PMN K012472 | DXN Jerry Wang [A&D Company, Limited]	UA-767PAC	2014-05-29
PMN K012472 | DXN Jerry Wang [A&D Company, Limited]	UA-631	2014-05-29
PMN K012472 | DXN Jerry Wang [A&D Company, Limited]	UA-611	2014-05-29
PMN K012472 | DXN A&D Engineering, Inc. [A&D Company, Limited]	UA-853LAC	2014-05-29
PMN K012472 | DXN A&D Engineering, Inc. [A&D Company, Limited]	UA-853AC	2014-05-29
PMN K012472 | DXN A&D Engineering, Inc. [A&D Company, Limited]	UA-851VL	2014-05-29
PMN K012472 | DXN A&D Engineering, Inc. [A&D Company, Limited]	UA-851V	2014-05-29
PMN K012472 | DXN A&D Engineering, Inc. [A&D Company, Limited]	UA-787EJ	2014-05-29
PMN K012472 | DXN A&D Engineering, Inc. [A&D Company, Limited]	UA-774AC	2014-05-29
PMN K012472 | DXN A&D Engineering, Inc. [A&D Company, Limited]	UA-767Plus	2014-05-29
PMN K012472 | DXN A&D Engineering, Inc. [A&D Company, Limited]	UA-767PVS	2014-05-29
PMN K012472 | DXN A&D Engineering, Inc. [A&D Company, Limited]	UA-767PVL	2014-05-29
PMN K012472 | DXN A&D Engineering, Inc. [A&D Company, Limited]	UA-767PV	2014-05-29
PMN K012472 | DXN A&D Engineering, Inc. [A&D Company, Limited]	UA-767PAC	2014-05-29
PMN K012472 | DXN A&D Engineering, Inc. [A&D Company, Limited]	UA-631	2014-05-29
PMN K012472 | DXN A&D Engineering, Inc. [A&D Company, Limited]	UA-611	2014-05-29
PMN K012472 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	UA-853LAC	2014-05-29
PMN K012472 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	UA-853AC	2014-05-29
PMN K012472 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	UA-851VL	2014-05-29
PMN K012472 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	UA-851V	2014-05-29
PMN K012472 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	UA-787EJ	2014-05-29
PMN K012472 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	UA-774AC	2014-05-29
PMN K012472 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	UA-767Plus	2014-05-29
PMN K012472 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	UA-767PVS	2014-05-29
PMN K012472 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	UA-767PVL	2014-05-29
PMN K012472 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	UA-767PV	2014-05-29
PMN K012472 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	UA-767PAC	2014-05-29
PMN K012472 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	UA-631	2014-05-29
PMN K012472 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	UA-611	2014-05-29
PMN K012472 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	UA-853LAC	2014-05-29
PMN K012472 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	UA-853AC	2014-05-29
PMN K012472 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	UA-851VL	2014-05-29
PMN K012472 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	UA-851V	2014-05-29
PMN K012472 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	UA-787EJ	2014-05-29
PMN K012472 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	UA-774AC	2014-05-29
PMN K012472 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	UA-767Plus	2014-05-29
PMN K012472 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	UA-767PVS	2014-05-29
PMN K012472 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	UA-767PVL	2014-05-29
PMN K012472 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	UA-767PV	2014-05-29
PMN K012472 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	UA-767PAC	2014-05-29
PMN K012472 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	UA-631	2014-05-29
PMN K012472 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	UA-611	2014-05-29
PMN K092447 | FLL A&D Engineering, Inc. [A&D Company, Limited]	Thermometer, Electronic, Clinical	2014-01-03
PMN K092447 | FLL A&D Engineering, Inc. [A&D Company, Limited]	DT-103	2014-01-03
PMN K092447 | FLL A&D Engineering, Inc. [A&D Company, Limited]	DT-102	2014-01-03
PMN K092447 | FLL A&D ENGINEERING, INC. [A&D Company, Limited]	Thermometer, Electronic, Clinical	2014-01-03
PMN K092447 | FLL A&D ENGINEERING, INC. [A&D Company, Limited]	DT-103	2014-01-03
PMN K092447 | FLL A&D ENGINEERING, INC. [A&D Company, Limited]	DT-102	2014-01-03
PMN K062027 | DXN Jerry Wang [A&D Company, Limited]	UA-789PC	2014-01-03
PMN K062027 | DXN Jerry Wang [A&D Company, Limited]	UA-789AC	2014-01-03
PMN K062027 | DXN Jerry Wang [A&D Company, Limited]	System, Measurement, Blood Pressure Non-invasive	2014-01-03
PMN K062027 | DXN A&D Engineering, Inc. [A&D Company, Limited]	UA-789PC	2014-01-03
PMN K062027 | DXN A&D Engineering, Inc. [A&D Company, Limited]	UA-789AC	2014-01-03
PMN K062027 | DXN A&D Engineering, Inc. [A&D Company, Limited]	System, Measurement, Blood Pressure Non-invasive	2014-01-03
PMN K062027 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	UA-789PC	2014-01-03
PMN K062027 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	UA-789AC	2014-01-03
PMN K062027 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	System, Measurement, Blood Pressure Non-invasive	2014-01-03
PMN K062027 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	UA-789PC	2014-01-03
PMN K062027 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	UA-789AC	2014-01-03
PMN K062027 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	System, Measurement, Blood Pressure Non-invasive	2014-01-03
PMN K061456 | DXN Jerry Wang [A&D Company, Limited]	A&D Medical UM-101	2014-01-03
PMN K061456 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	A&D Medical UM-101	2014-01-03
PMN K040229 | DXN Jerry Wang [A&D Company, Limited]	UB-351	2014-01-03
PMN K040229 | DXN Jerry Wang [A&D Company, Limited]	System, Measurement, Blood Pressure Non-invasive	2014-01-03
PMN K040229 | DXN A&D Engineering, Inc. [A&D Company, Limited]	UB-351	2014-01-03
PMN K040229 | DXN A&D Engineering, Inc. [A&D Company, Limited]	System, Measurement, Blood Pressure Non-invasive	2014-01-03
PMN K040229 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	UB-351	2014-01-03
PMN K040229 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	System, Measurement, Blood Pressure Non-invasive	2014-01-03
PMN K040229 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	UB-351	2014-01-03
PMN K040229 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	System, Measurement, Blood Pressure Non-invasive	2014-01-03
PMN K010828 | DXN Jerry Wang [A&D Company, Limited]	TM-2655P	2014-01-03
PMN K010828 | DXN Jerry Wang [A&D Company, Limited]	TM-2655	2014-01-03
PMN K010828 | DXN Jerry Wang [A&D Company, Limited]	System, Measurement, Blood Pressure Non-invasive	2014-01-03
PMN K010828 | DXN A&D Engineering, Inc. [A&D Company, Limited]	TM-2655P	2014-01-03
PMN K010828 | DXN A&D Engineering, Inc. [A&D Company, Limited]	TM-2655	2014-01-03
PMN K010828 | DXN A&D Engineering, Inc. [A&D Company, Limited]	System, Measurement, Blood Pressure Non-invasive	2014-01-03
PMN K010828 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	TM-2655P	2014-01-03
PMN K010828 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	TM-2655	2014-01-03
PMN K010828 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	System, Measurement, Blood Pressure Non-invasive	2014-01-03
PMN K002182 | FLL A&D Engineering, Inc. [A&D Company, Limited]	UT-302	2014-01-03
PMN K002182 | FLL A&D Engineering, Inc. [A&D Company, Limited]	Thermometer, Electronic, Clinical	2014-01-03
PMN K002182 | FLL A&D ENGINEERING, INC. [A&D Company, Limited]	UT-302	2014-01-03
PMN K002182 | FLL A&D ENGINEERING, INC. [A&D Company, Limited]	Thermometer, Electronic, Clinical	2014-01-03
PMN K992808 | DXN Jerry Wang [A&D Company, Limited]	TM-2430	2013-08-28
PMN K992808 | DXN Jerry Wang [A&D Company, Limited]	TM-2430-DP3	2013-08-28
PMN K992808 | DXN Jerry Wang [A&D Company, Limited]	Ambulatory Blood Pressure Monitor	2013-08-28
PMN K992808 | DXN A&D Engineering, Inc. [A&D Company, Limited]	TM-2430	2013-08-28
PMN K992808 | DXN A&D Engineering, Inc. [A&D Company, Limited]	TM-2430-DP3	2013-08-28
PMN K992808 | DXN A&D Engineering, Inc. [A&D Company, Limited]	Ambulatory Blood Pressure Monitor	2013-08-28
PMN K992808 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	TM-2430	2013-08-28
PMN K992808 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	TM-2430-DP3	2013-08-28
PMN K992808 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	Ambulatory Blood Pressure Monitor	2013-08-28
PMN K992808 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	TM-2430	2013-08-28
PMN K992808 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	TM-2430-DP3	2013-08-28
PMN K992808 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	Ambulatory Blood Pressure Monitor	2013-08-28
PMN K982481 | DXN Jerry Wang [A&D Company, Limited]	blood pressure monitor	2012-08-22
PMN K982481 | DXN Jerry Wang [A&D Company, Limited]	blood pressure monitor	2012-08-22
PMN K982481 | DXN Jerry Wang [A&D Company, Limited]	UA-767PCJ	2012-08-22
PMN K982481 | DXN Jerry Wang [A&D Company, Limited]	UA-767PCJ	2012-08-22
PMN K982481 | DXN Jerry Wang [A&D Company, Limited]	UA-767PC	2012-08-22
PMN K982481 | DXN Jerry Wang [A&D Company, Limited]	UA-767PC	2012-08-22
PMN K982481 | DXN A&D Engineering, Inc. [A&D Company, Limited]	blood pressure monitor	2012-08-22
PMN K982481 | DXN A&D Engineering, Inc. [A&D Company, Limited]	UA-767PCJ	2012-08-22
PMN K982481 | DXN A&D Engineering, Inc. [A&D Company, Limited]	UA-767PC	2012-08-22
PMN K982481 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	blood pressure monitor	2012-08-22
PMN K982481 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	UA-767PCJ	2012-08-22
PMN K982481 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	UA-767PC	2012-08-22
PMN K982481 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	blood pressure monitor	2012-08-22
PMN K982481 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	UA-767PCJ	2012-08-22
PMN K982481 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	UA-767PC	2012-08-22
PMN K111686 | DXN Jerry Wang [A&D Company, Limited]	UA-1030T	2011-12-07
PMN K111686 | DXN Jerry Wang [A&D Company, Limited]	UA-1030T	2011-12-07
PMN K111686 | DXN Jerry Wang [A&D Company, Limited]	UA-1020	2011-12-07
PMN K111686 | DXN Jerry Wang [A&D Company, Limited]	UA-1020	2011-12-07
PMN K111686 | DXN Jerry Wang [A&D Company, Limited]	UA-1010	2011-12-07
PMN K111686 | DXN Jerry Wang [A&D Company, Limited]	UA-1010	2011-12-07
PMN K111686 | DXN Jerry Wang [A&D Company, Limited]	Digital Blood Pressure Monitor	2011-12-07
PMN K111686 | DXN Jerry Wang [A&D Company, Limited]	Digital Blood Pressure Monitor	2011-12-07
PMN K111686 | DXN A&D Engineering, Inc. [A&D Company, Limited]	UA-1030T	2011-12-07
PMN K111686 | DXN A&D Engineering, Inc. [A&D Company, Limited]	UA-1020	2011-12-07
PMN K111686 | DXN A&D Engineering, Inc. [A&D Company, Limited]	UA-1010	2011-12-07
PMN K111686 | DXN A&D Engineering, Inc. [A&D Company, Limited]	Digital Blood Pressure Monitor	2011-12-07
PMN K111686 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	UA-1030T	2011-12-07
PMN K111686 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	UA-1020	2011-12-07
PMN K111686 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	UA-1010	2011-12-07
PMN K111686 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	Digital Blood Pressure Monitor	2011-12-07
PMN K111686 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	UA-1030T	2011-12-07
PMN K111686 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	UA-1020	2011-12-07
PMN K111686 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	UA-1010	2011-12-07
PMN K111686 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	Digital Blood Pressure Monitor	2011-12-07
PMN K082734 | DXN Jerry Wang [A&D Company, Limited]	UA-851THW	2011-12-07
PMN K082734 | DXN Jerry Wang [A&D Company, Limited]	UA-851PBT	2011-12-07
PMN K082734 | DXN Jerry Wang [A&D Company, Limited]	Digital Blood Pressure Monitor	2011-12-07
PMN K082734 | DXN A&D Engineering, Inc. [A&D Company, Limited]	UA-851THW	2011-12-07
PMN K082734 | DXN A&D Engineering, Inc. [A&D Company, Limited]	UA-851PBT	2011-12-07
PMN K082734 | DXN A&D Engineering, Inc. [A&D Company, Limited]	Digital Blood Pressure Monitor	2011-12-07
PMN K082734 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	UA-851THW	2011-12-07
PMN K082734 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	UA-851PBT	2011-12-07
PMN K082734 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	Digital Blood Pressure Monitor	2011-12-07
PMN K082734 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	UA-851THW	2011-12-07
PMN K082734 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	UA-851PBT	2011-12-07
PMN K082734 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	Digital Blood Pressure Monitor	2011-12-07
PMN K043217 | DXN Jerry Wang [A&D Company, Limited]	UA-767PBT	2005-09-09
PMN K043217 | DXN Jerry Wang [A&D Company, Limited]	UA-767PBT-CI	2005-09-09
PMN K043217 | DXN Jerry Wang [A&D Company, Limited]	UA-767PBT-C	2005-09-09
PMN K043217 | DXN Jerry Wang [A&D Company, Limited]	DIGITAL BLOOD PRESSURE MONITOR	2005-09-09
PMN K043217 | DXN A&D Engineering, Inc. [A&D Company, Limited]	UA-767PBT	2005-09-09
PMN K043217 | DXN A&D Engineering, Inc. [A&D Company, Limited]	UA-767PBT-CI	2005-09-09
PMN K043217 | DXN A&D Engineering, Inc. [A&D Company, Limited]	UA-767PBT-C	2005-09-09
PMN K043217 | DXN A&D Engineering, Inc. [A&D Company, Limited]	DIGITAL BLOOD PRESSURE MONITOR	2005-09-09
PMN K043217 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	UA-767PBT	2005-09-09
PMN K043217 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	UA-767PBT-CI	2005-09-09
PMN K043217 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	UA-767PBT-C	2005-09-09
PMN K043217 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	DIGITAL BLOOD PRESSURE MONITOR	2005-09-09
PMN K043217 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	UA-767PBT	2005-09-09
PMN K043217 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	UA-767PBT-CI	2005-09-09
PMN K043217 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	UA-767PBT-C	2005-09-09
PMN K043217 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	DIGITAL BLOOD PRESSURE MONITOR	2005-09-09
PMN K042967 | DXN Jerry Wang [A&D Company, Limited]	UB-542	2005-09-09
PMN K042967 | DXN Jerry Wang [A&D Company, Limited]	UB-521	2005-09-09
PMN K042967 | DXN Jerry Wang [A&D Company, Limited]	UB-512	2005-09-09
PMN K042967 | DXN Jerry Wang [A&D Company, Limited]	DIGITAL BLOOD PRESSURE MONITOR	2005-09-09
PMN K042967 | DXN A&D Engineering, Inc. [A&D Company, Limited]	UB-542	2005-09-09
PMN K042967 | DXN A&D Engineering, Inc. [A&D Company, Limited]	UB-521	2005-09-09
PMN K042967 | DXN A&D Engineering, Inc. [A&D Company, Limited]	UB-512	2005-09-09
PMN K042967 | DXN A&D Engineering, Inc. [A&D Company, Limited]	DIGITAL BLOOD PRESSURE MONITOR	2005-09-09
PMN K042967 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	UB-542	2005-09-09
PMN K042967 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	UB-521	2005-09-09
PMN K042967 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	UB-512	2005-09-09
PMN K042967 | DXN A&D ENGINEERING, INC. [A&D Company, Limited]	DIGITAL BLOOD PRESSURE MONITOR	2005-09-09
PMN K042967 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	UB-542	2005-09-09
PMN K042967 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	UB-521	2005-09-09
PMN K042967 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	UB-512	2005-09-09
PMN K042967 | DXN A&D Company, Limited - Tech Center [A&D Company, Limited]	DIGITAL BLOOD PRESSURE MONITOR	2005-09-09
FRW Jerry Wang [A&D Company, Limited]	UC-352BLE-V	2005-09-09
FRW Jerry Wang [A&D Company, Limited]	UC-352BLE-V	2005-09-09
FRW A&D Engineering, Inc. [A&D Company, Limited]	UC-352BLE-V	2005-09-09
FRW A&D ENGINEERING, INC. [A&D Company, Limited]	UC-352BLE-V	2005-09-09
FRW A&D Company, Limited - Tech Center [A&D Company, Limited]	UC-352BLE-V	2005-09-09

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• Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP180046 Supplement NumberS064 Date Received01/10/2023 Decision Date02/01/2023 Product Code EZW  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP190006 Supplement NumberS064 Date Received01/10/2023 Decision Date02/01/2023 Product Code QON  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• ABBOTT VASCULAR INC.400 Saginaw Driveredwood City, CA 94063 PMA NumberP960043 Supplement NumberS120 Date Received11/21/2022 Decision Date01/31/2023 Product Code MGB  Advisory Committee Cardiovascular Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• ABBOTT VASCULAR3200 Lakeside Drivesanta Clara, CA 95054 PMA NumberP040012 Supplement NumberS064 Date Received11/21/2022 Decision Date01/31/2023 Product Code NIM  Advisory Committee Cardiovascular Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• ABBOTT VASCULAR INC.3200 Lakeside Drivesanta Clara, CA 95054 PMA NumberP040038 Supplement NumberS041 Date Received11/21/2022 Decision Date01/31/2023 Product Code NIM  Advisory Committee Cardiovascular Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• ABBOTT VASCULAR INC.3200 Lakeside Drivesanta Clara, CA 92054 PMA NumberP110028 Supplement NumberS023 Date Received11/21/2022 Decision Date01/31/2023 Product Code NIO  Advisory Committee Cardiovascular Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Medical177 Country Road B Eastst. Paul, MN 55117 PMA NumberP100009 Supplement NumberS051 Date Received01/03/2023 Decision Date01/31/2023 Product Code NKM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• ABBOTT VASCULAR (IDEF TECHNOLOGIES INC)3200 Lakeside Drivesanta Clara, CA 95054 PMA NumberP120020 Supplement NumberS030 Date Received11/21/2022 Decision Date01/31/2023 Product Code NIP  Advisory Committee Cardiovascular Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• ABBOTT VASCULAR DEVICES3200 Lakeside Drivesanta Clara, CA 95054 PMA NumberP050007 Supplement NumberS043 Date Received11/21/2022 Decision Date01/31/2023 Product Code MGB  Advisory Committee Cardiovascular Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Laboratories100 Abbott Park Rd.ap5n-2, Dept. 09vbabbott Park, IL 60064 PMA NumberP080023 Supplement NumberS039 Date Received01/06/2023 Decision Date01/27/2023 Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Laboratories100 Abbott Park Rd.ap5n-2 Dept 09vbabbott Park, IL 60064-6070 PMA NumberP980007 Supplement NumberS048 Date Received01/06/2023 Decision Date01/27/2023 Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Laboratories100 Abbott Park Rd.ap5n-2, Dept. 09vbabbott Park, IL 60064-3500 PMA NumberP060035 Supplement NumberS037 Date Received01/06/2023 Decision Date01/27/2023 Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Laboratories100 Abbott Park Rd.dept 09v6, Bldg. Ap5-2abbott Park, IL 60064-6088 PMA NumberP110029 Supplement NumberS041 Date Received01/06/2023 Decision Date01/27/2023 Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Laboratories100 Abbott Park Rd.abbott Park, IL 60064-3500 PMA NumberP910007 Supplement NumberS059 Date Received01/06/2023 Decision Date01/27/2023 Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Medical177 County Road B. Eastst. Paul, MN 55117 PMA NumberP810002 Supplement NumberS116 Date Received12/28/2022 Decision Date01/27/2023 Product Code LWQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Laboratories09v6 Ap5-2n100 Abbott Park Roadabbott Park, IL 60064 PMA NumberP120008 Supplement NumberS021 Date Received01/06/2023 Decision Date01/27/2023 Product Code LOK  Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• ABBOTT LABORATORIES INC100 Abbott Park Roaddept 9va- Ap8-1abbott Park, IL 60064 PMA NumberP050051 Supplement NumberS049 Date Received01/06/2023 Decision Date01/27/2023 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Laboratories100 Abbott Park Roaddept: 09aa Bldg: Ap8-1abbott Park, IL 60064 PMA NumberP210003 Supplement NumberS005 Date Received01/06/2023 Decision Date01/27/2023 Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• ABBOTT DIABETES CARE INC.1360 South Loop Dr.alameda, CA 94502-7000 PMA NumberP160030 Supplement NumberS052 Date Received12/19/2022 Decision Date01/17/2023 Product Code PZE  Advisory Committee Clinical Chemistry Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
• ABBOTT MOLECULAR1300 East Touhy Avenuedes Plaines, IL 60018 PMA NumberP160044 Supplement NumberS005 Date Received12/20/2022 Decision Date01/13/2023 Product Code PAB  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Molecular, Inc.1300 E Touhy Avedes Plaines, IL 60018 PMA NumberP200013 Supplement NumberS012 Date Received12/20/2022 Decision Date01/13/2023 Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Medical6035 Stoneridge Drivepleasanton, CA 94588 PMA NumberP160054 Supplement NumberS050 Date Received10/31/2022 Decision Date01/10/2023 Product Code DSQ  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Abbott Medical6035 Stoneridge Drivepleasanton, CA 94588 PMA NumberP060040 Supplement NumberS089 Date Received10/31/2022 Decision Date01/10/2023 Product Code DSQ  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Abbott Medical387 Technology Circle, Nwsuite 500atlanta, GA 30313 PMA NumberP100045 Supplement NumberS064 Date Received12/09/2022 Decision Date01/06/2023 Product Code MOM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• ABIOMED, INC.22 Cherry Hill Dr.danvers, MA 01923 PMA NumberP140003 Supplement NumberS106 Date Received10/14/2022 Decision Date01/06/2023 Product Code OZD  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• Asahi Kasei Medical Co., Ltd.1-105 Kanda Jinbochochiyoda-kutokyo 101-8-8101 PMA NumberP820033 Supplement NumberS016 Date Received12/09/2022 Decision Date01/05/2023 Product Code MDP  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Allergan2525 Dupont Dr.irvine, CA 92612 PMA NumberP990074 Supplement NumberS050 Date Received04/04/2022 Decision Date12/29/2022 Product Code FWM  Advisory Committee General & Plastic Surgery Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• Allergan2525 Dupont Dr.irvine, CA 92612 PMA NumberP020056 Supplement NumberS059 Date Received04/04/2022 Decision Date12/29/2022 Product Code FTR  Advisory Committee General & Plastic Surgery Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• AtriCure, Inc.7555 Innovation Waywest Chester, OH 45040 PMA NumberP200002 Supplement NumberS004 Date Received09/28/2022 Decision Date12/27/2022 Product Code OCM  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Abbott Molecular, Inc.1300 E Touhy Avedes Plaines, IL 60018 PMA NumberP200013 Supplement NumberS011 Date Received12/07/2022 Decision Date12/22/2022 Product Code MKT  Advisory Committee Microbiology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• Alcon Laboratories, LLC6201 South Freewayfort Worth, TX 76134 PMA NumberP190018 Supplement NumberS021 Date Received11/22/2022 Decision Date12/20/2022 Product Codes MJP HQL  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Alcon Research, Ltd.6201 South Freewayfort Worth, TX 76134-2099 PMA NumberP040020 Supplement NumberS104 Date Received11/22/2022 Decision Date12/20/2022 Product Code MFK  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• ALCON LABORATORIES, INC.6201 South Freeway Dr.fort Worth, TX 76134 PMA NumberP930014 Supplement NumberS144 Date Received11/22/2022 Decision Date12/20/2022 Product Code HQL  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• ABBOTT VASCULAR (IDEF TECHNOLOGIES INC)3200 Lakeside Drivesanta Clara, CA 95054 PMA NumberP120020 Supplement NumberS029 Date Received09/30/2022 Decision Date12/20/2022 Product Code NIP  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP180046 Supplement NumberS062 Date Received09/29/2022 Decision Date12/19/2022 Product Code EZW  Advisory Committee Gastroenterology/Urology Supplement Typenormal 180 Day Track Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP190006 Supplement NumberS062 Date Received09/29/2022 Decision Date12/19/2022 Product Code QON  Advisory Committee Gastroenterology/Urology Supplement Typenormal 180 Day Track Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• ABBOTT VASCULAR INC.400 Saginaw Driveredwood City, CA 94063 PMA NumberP960043 Supplement NumberS119 Date Received11/16/2022 Decision Date12/16/2022 Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• ABBOTT VASCULAR DEVICES3200 Lakeside Drivesanta Clara, CA 95054 PMA NumberP050007 Supplement NumberS042 Date Received11/16/2022 Decision Date12/16/2022 Product Code MGB  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Medical177 Country Road B Eastst. Paul, MN 55117 PMA NumberP100009 Supplement NumberS050 Date Received11/16/2022 Decision Date12/15/2022 Product Code NKM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Medical177 County Road B. Eastst. Paul, MN 55117 PMA NumberP190023 Supplement NumberS011 Date Received11/18/2022 Decision Date12/14/2022 Product Code NPT  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Medical177 County Road B. Eastst. Paul, MN 55117 PMA NumberP100029 Supplement NumberS049 Date Received11/18/2022 Decision Date12/14/2022 Product Code LWR  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Medical177 County Road B. Eastst. Paul, MN 55117 PMA NumberP040021 Supplement NumberS051 Date Received11/18/2022 Decision Date12/14/2022 Product Code LWR  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Medical15900 Valley View Courtsylmar, CA 91335 PMA NumberP960030 Supplement NumberS077 Date Received09/08/2022 Decision Date12/07/2022 Product Code NVN  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Abbott Medical15900 Valley View Courtsylmar, CA 91335 PMA NumberP140033 Supplement NumberS076 Date Received09/08/2022 Decision Date12/07/2022 Product Codes LWP NVN  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Abbott Laboratories100 Abbott Park Rd.dept 09v6, Bldg. Ap5-2abbott Park, IL 60064-6088 PMA NumberP110029 Supplement NumberS040 Date Received11/07/2022 Decision Date12/07/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• ABBOTT LABORATORIES INC100 Abbott Park Roaddept 9va- Ap8-1abbott Park, IL 60064 PMA NumberP050051 Supplement NumberS048 Date Received11/07/2022 Decision Date12/07/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Laboratories100 Abbott Park Roaddept: 09aa Bldg: Ap8-1abbott Park, IL 60064 PMA NumberP210003 Supplement NumberS003 Date Received11/07/2022 Decision Date12/07/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Medical177 County Road B. Eastst. Paul, MN 55117 PMA NumberP100029 Supplement NumberS048 Date Received10/20/2022 Decision Date12/06/2022 Product Code LWR  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abiomed, Inc.22 Cherry Hill Drivedanvers, MA 01923 PMA NumberP170011 Supplement NumberS047 Date Received11/03/2022 Decision Date12/05/2022 Product Code PYX  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• AcuFocus, Inc.32 Discoverysuite 200irvine, CA 92618 PMA NumberP210005 Supplement NumberS004 Date Received11/04/2022 Decision Date12/02/2022 Product Code POE  Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
• Abbott Molecular, Inc.1300 East Touhy Avenuedes Plaines, IL 60018 PMA NumberP170041 Supplement NumberS006 Date Received12/17/2021 Decision Date12/01/2022 Product Code OWD  Advisory Committee Clinical TrialsNCT02719574 Supplement Typenormal 180 Day Track Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• ARJ Medical Inc.209 State Street Eoldsmar, FL 34677 PMA NumberP170022 Supplement NumberS001 Date Received05/04/2022 Decision Date11/30/2022 Product Code OZA  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Abbott Medical177 County Road B. Eastst. Paul, MN 55117 PMA NumberP100029 Supplement NumberS047 Date Received10/20/2022 Decision Date11/29/2022 Product Code LWR  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Molecular, Inc.1300 E. Touhy Avenuedes Plaines, IL 60018 PMA NumberP210022 Supplement NumberS002 Date Received11/03/2022 Decision Date11/28/2022 Product Code PAB  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• ABBOTT VASCULAR (IDEF TECHNOLOGIES INC)3200 Lakeside Drivesanta Clara, CA 95054 PMA NumberP120020 Supplement NumberS028 Date Received09/30/2022 Decision Date11/22/2022 Product Code NIP  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Abbott Medical177 Country Road B Eastst. Paul, MN 55117 PMA NumberP100009 Supplement NumberS049 Date Received11/09/2022 Decision Date11/20/2022 Product Code NKM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• ATRICURE INC.7555 Innovation Waymason, OH 45040 PMA NumberP100046 Supplement NumberS013 Date Received03/01/2022 Decision Date11/15/2022 Product Code OCM  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Abbott Medical6035 Stoneridge Drivepleasanton, CA 94588 PMA NumberP060040 Supplement NumberS088 Date Received10/25/2022 Decision Date11/10/2022 Product Code DSQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Medical177 County Road B. Eastst. Paul, MN 55117 PMA NumberP190023 Supplement NumberS010 Date Received08/12/2022 Decision Date11/09/2022 Product Code NPT  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Anika Therapeutics, Inc.32 Wiggins Avenuebedford, MA 01730 PMA NumberP030019 Supplement NumberS027 Date Received10/12/2022 Decision Date11/08/2022 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Anika Therapeutics, Inc.32 Wiggins Avenuebedford, MA 01730 PMA NumberP090031 Supplement NumberS015 Date Received10/12/2022 Decision Date11/08/2022 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Anika Therapeutics, Inc.32 Wiggins Avenuebedford, MA 01730 PMA NumberP090031 Supplement NumberS014 Date Received10/03/2022 Decision Date11/04/2022 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Agilent Technologies, Inc.5301 Stevens Creek Blvdsanta Clara, CA 95051 PMA NumberP150013 Supplement NumberS025 Date Received08/08/2022 Decision Date11/03/2022 Product Code PLS  Advisory Committee Pathology Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP180046 Supplement NumberS061 Date Received09/19/2022 Decision Date11/01/2022 Product Code EZW  Advisory Committee Gastroenterology/Urology Supplement Typenormal 180 Day Track Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP190006 Supplement NumberS061 Date Received09/19/2022 Decision Date11/01/2022 Product Code QON  Advisory Committee Gastroenterology/Urology Supplement Typenormal 180 Day Track Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Avive Solutions, Inc.223 Mississippi Street, Unit 2san Francisco, CA 94107 PMA NumberP210015 Date Received04/06/2021 Decision Date10/31/2022 Product Code MKJ  Advisory Committee Cardiovascular Expedited Review Granted? No
• Abbott Medical6901 Preston Roadplano, TX 75024 PMA NumberP010032 Supplement NumberS194 Date Received09/29/2022 Decision Date10/28/2022 Product Code LGW  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Medical6901 Prestion Roadplano, TX 75024 PMA NumberP140009 Supplement NumberS080 Date Received09/29/2022 Decision Date10/28/2022 Product Codes MHY PJS NHL  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP170023 Supplement NumberS013 Date Received09/27/2022 Decision Date10/26/2022 Product Code LNM  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP170023 Supplement NumberS012 Date Received09/27/2022 Decision Date10/26/2022 Product Code LNM  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Laboratories100 Abbott Park Rd.ap5n-2, Dept. 09vbabbott Park, IL 60064 PMA NumberP080023 Supplement NumberS038 Date Received09/27/2022 Decision Date10/25/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Laboratories100 Abbott Park Rd.ap5n-2, Dept. 09vbabbott Park, IL 60064-3500 PMA NumberP060035 Supplement NumberS036 Date Received09/27/2022 Decision Date10/25/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Molecular, Inc.1300 E Touhy Avedes Plaines, IL 60018 PMA NumberP200013 Supplement NumberS009 Date Received09/21/2022 Decision Date10/24/2022 Product Code MKT  Advisory Committee Microbiology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• Abbott Medical6901 Prestion Roadplano, TX 75024 PMA NumberP140009 Supplement NumberS079 Date Received09/21/2022 Decision Date10/17/2022 Product Code MHY  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Medical177 Country Road B Eastst. Paul, MN 55117 PMA NumberP100009 Supplement NumberS048 Date Received10/11/2022 Decision Date10/17/2022 Product Code NKM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Medical6035 Stoneridge Drivepleasanton, CA 94588 PMA NumberP160054 Supplement NumberS049 Date Received09/15/2022 Decision Date10/14/2022 Product Code DSQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Medical6035 Stoneridge Drivepleasanton, CA 94588 PMA NumberP060040 Supplement NumberS087 Date Received09/15/2022 Decision Date10/14/2022 Product Code DSQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• AtriCure, Inc.7555 Innovation Waywest Chester, OH 45040 PMA NumberP200002 Supplement NumberS003 Date Received09/13/2022 Decision Date10/13/2022 Product Code OCM  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
• Abbott Laboratories100 Abbott Park Rd.dept 09v6, Bldg. Ap5-2abbott Park, IL 60064-6088 PMA NumberP110029 Supplement NumberS039 Date Received09/14/2022 Decision Date10/12/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• ABBOTT LABORATORIES INC100 Abbott Park Roaddept 9va- Ap8-1abbott Park, IL 60064 PMA NumberP050051 Supplement NumberS047 Date Received09/14/2022 Decision Date10/12/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Laboratories09v6 Ap5-2n100 Abbott Park Roadabbott Park, IL 60064 PMA NumberP120008 Supplement NumberS020 Date Received09/14/2022 Decision Date10/12/2022 Product Code LOK  Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Laboratories100 Abbott Park Roaddept: 09aa Bldg: Ap8-1abbott Park, IL 60064 PMA NumberP210003 Supplement NumberS002 Date Received09/14/2022 Decision Date10/12/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Laboratories100 Abbott Park Rd.ap5n-2, Dept. 09vbabbott Park, IL 60064-3500 PMA NumberP060035 Supplement NumberS035 Date Received09/14/2022 Decision Date10/12/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Laboratories100 Abbott Park Rd.ap5n-2, Dept. 09vbabbott Park, IL 60064 PMA NumberP080023 Supplement NumberS037 Date Received09/14/2022 Decision Date10/12/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Laboratories100 Abbott Park Rd.ap5n-2 Dept 09vbabbott Park, IL 60064-6070 PMA NumberP980007 Supplement NumberS047 Date Received09/14/2022 Decision Date10/12/2022 Product Code MTG  Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Laboratories100 Abbott Park Rd.abbott Park, IL 60064-3500 PMA NumberP910007 Supplement NumberS058 Date Received09/14/2022 Decision Date10/12/2022 Product Code MTF  Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abiomed, Inc.22 Cherry Hill Drivedanvers, MA 01923 PMA NumberP170011 Supplement NumberS046 Date Received09/15/2022 Decision Date10/11/2022 Product Code PYX  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Medical15900 Valley View Courtsylmar, CA 91342 PMA NumberP150035 Supplement NumberS002 Date Received09/21/2022 Decision Date10/06/2022 Product Code PNJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• APOLLO ENDOSURGERY INC1120 S Capital Of Tx Hwybldg 1, Ste 300austin, TX 78746-0000 PMA NumberP140008 Supplement NumberS024 Date Received07/11/2022 Decision Date10/05/2022 Product Code LTI  Advisory Committee Gastroenterology/Urology Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• Allergan2525 Dupont Dr.irvine, CA 92612 PMA NumberP020056 Supplement NumberS058 Date Received04/01/2022 Decision Date10/05/2022 Product Code FTR  Advisory Committee General & Plastic Surgery Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Allergan2525 Dupont Dr.irvine, CA 92612 PMA NumberP990074 Supplement NumberS049 Date Received04/01/2022 Decision Date10/05/2022 Product Code FWM  Advisory Committee General & Plastic Surgery Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Altacor Ltd.merlin House, Brunel Roadtheale RG7 4 PMA NumberP960011 Supplement NumberS034 Date Received09/08/2022 Decision Date10/03/2022 Product Code LZP  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Laboratories100 Abbott Park Roaddept: 09aa Bldg: Ap8-1abbott Park, IL 60064 PMA NumberP210003 Supplement NumberS001 Date Received09/09/2022 Decision Date09/30/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Medical15900 Valley View Courtsylmar, CA 91335 PMA NumberP970013 Supplement NumberS091 Date Received07/27/2022 Decision Date09/30/2022 Product Code LWO  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Abbott Laboratories100 Abbott Park Rd.dept 09v6, Bldg. Ap5-2abbott Park, IL 60064-6088 PMA NumberP110029 Supplement NumberS038 Date Received09/09/2022 Decision Date09/30/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Medical15900 Valley View Courtsylmar, CA 91335 PMA NumberP030035 Supplement NumberS191 Date Received07/27/2022 Decision Date09/30/2022 Product Code NKE  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• ABBOTT LABORATORIES INC100 Abbott Park Roaddept 9va- Ap8-1abbott Park, IL 60064 PMA NumberP050051 Supplement NumberS046 Date Received09/09/2022 Decision Date09/30/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Medical15900 Valley View Courtsylmar, CA 91335 PMA NumberP880086 Supplement NumberS325 Date Received07/27/2022 Decision Date09/30/2022 Product Code DXY  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Abbott Medical15900 Valley View Courtsylmar, CA 91335 PMA NumberP140033 Supplement NumberS075 Date Received07/27/2022 Decision Date09/30/2022 Product Codes LWP NVN  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• ALCON LABORATORIES6201 South Freewayfort Worth, TX 76134 PMA NumberP990023 Supplement NumberS018 Date Received08/24/2022 Decision Date09/22/2022 Product Code LZP  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• AD BIOTECH CO.,LTD
• AD Cosmetics Co., Ltd.
• Adam E-commerce (Xiamen) Co., Ltd.
• ADBIOTECH CO., LTD.
• Adblock Co., Ltd.
• ADF HI-TECH DISINFECTANTS CO., LTD.
• Aekyung Ind. Co., Ltd.
• Aekyung Ind. Co., Ltd._Chungyang Factory
• Aekyung Industrial Co., Ltd.
• ACESO DENTAL LABORATORY COMPANY LIMITED
• ADAM ELEMENTS INTERNATIONAL CO., LTD.
• Aibodent Biotechnology Co., Ltd
• Alliedstar Medical Equipment Co., Ltd.
• Amsinomed Medical Co.,Ltd
• Anhui Annuy Latex Products Co.,Ltd.
• Anhui Zhanzun Industrial Co.,Ltd.
• AP MDS Co., Ltd.
• Around Body Co., Ltd.
• Austar Hearing Science & Technology (Xiamen) Co., Ltd men) Co., Ltd.
• AXELGAARD MANUFACTURING CO., LTD.
• Asia Pacific Medical Technology Development Company Limited

Related Finance Registrations

NCAGE Code	SERU2	A & D COMPANY LIMITED
NCAGE Code	SJT60	A&D COMPANY LIMITED
NCAGE Code	SEZ20	A & D COMPANY, LIMITED
NCAGE Code	S5949	A AND D COMPANY LTD
NCAGE Code	SJNF6	A&D Company, Limited
CAGE Code	SJT60	A&D COMPANY LIMITED
CAGE Code	S5949	A AND D COMPANY LTD
CAGE Code	SEZ20	A & D COMPANY, LIMITED
CAGE Code	SERU2	A & D COMPANY LIMITED

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092925845	Tokyo ,Japan -> Savannah, Georgia	WEIGHING INSTRUMENT & MEDICAL EQUIPMENTS INVOICE NO. 5500054878/879/880/881/ 882/895/901/924/925	1480 CTN
2020092925845	Tokyo ,Japan -> Savannah, Georgia	WEIGHING INSTRUMENT & MEDICAL EQUIPMENTS INVOICE NO. 5500054878/879/880/881/ 882/895/901/924/925	1480 CTN
2020092553919	Tokyo ,Japan -> Los Angeles, California	WEIGHING MACHINERY HS CODE 842382 901600 903300 902780	11 CTN
202009194371	Yantian,China (Mainland) -> Savannah, Georgia	DIGITAL BLOOD PRESSURE MONITOR IP67 COMPACT B G/0.5G IP67 CHECKWEIGHING SCALE 3KG/0.5G BLE DIGITAL BLOOD PRESSURE MONITOR WRIST DIGITAL . .	5669 CTN
202009194371	Yantian,China (Mainland) -> Savannah, Georgia	DIGITAL BLOOD PRESSURE MONITOR PRECISION HEAR DIGITAL BLOOD PRESSURE MONITOR W/BLE . .	5669 CTN
202009194371	Yantian,China (Mainland) -> Savannah, Georgia	DIGITAL BLOOD PRESSURE MONITOR DIGITAL BLOOD MONITOR WRIST DIGITAL BLOOD PRESSURE MONITOR W/BLE . .	5669 CTN
202009188679	Hong Kong,Hong Kong -> Savannah, Georgia	DIGITAL BLOOD PRESSURE MONITOR W/BLE DIGITAL BLOOD PRESSURE MONITOR	1920 CTN
2020091136334	Tokyo ,Japan -> Savannah, Georgia	WEIGHING INSTRUMENTS & MEDICAL EQUIPMENTS INVOICE NO. 5500054779/799/818/819/820/821	1002 CTN
202008293246	Hong Kong,Hong Kong -> Savannah, Georgia	DIGITAL BLOOD PRESSURE MONITOR	4905 CTN
202008293246	Hong Kong,Hong Kong -> Savannah, Georgia	DIGITAL BLOOD PRESSURE MONITOR DIGITAL BLOOD PRESSURE MONITOR W/BLE	4905 CTN
202008293246	Hong Kong,Hong Kong -> Savannah, Georgia	DIGITAL BLOOD PRESSURE MONITOR DIGITAL BLOOD PRESSURE MONITOR W/BLE PRECISION HEALTH SCALE W/BLE	4905 CTN
2020082857589	Tokyo ,Japan -> Los Angeles, California	DIGITAL ELECTRONIC TYPE COUNTING SCALES HS CODE 902780 842381 854442 903300 903180	27 CTN
2020082721180	Hong Kong,Hong Kong -> Savannah, Georgia	LARGE CUFF D LIGHTBLUE BOXED OPTI CUFF BULK M LARGE SLIMFIT CUFF BULK LARGE SLIMFIT CUFF BOXED MEDIUM SLIMFIT CUFF BOXED WIDE RANGE C UFF BULK DIGITAL BLOOD PRESSURE MONITOR	5345 CTN
2020082721180	Hong Kong,Hong Kong -> Savannah, Georgia	DIGITAL BLOOD PRESSURE MONITOR DIGITAL WRIST BLOOD PRESSURE MONITOR	5345 CTN
2020082721180	Hong Kong,Hong Kong -> Savannah, Georgia	AC ADAPTER FOR BPM A PLUG BOXED DIGITAL BLOOD PRESSURE MONITOR	5345 CTN