Ab Medica

FDA Filings

This page includes the latest FDA filings for Ab Medica. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
GUDID E496COEC351000 AB MEDICA	REUSABLE CANNULA TROCAR WITH LOCK TAP D=3.5MM L=100MM COEC35100	2021-08-02
GUDID E496COEC350750 AB MEDICA	REUSABLE CANNULA TROCAR WITH LOCK TAP D=3.5MM L=75MM COEC35075	2021-08-02
GUDID E496COEC350600 AB MEDICA	REUSABLE CANNULA TROCAR WITH LOCK TAP D=3.5MM L=60MM COEC35060	2021-08-02
GUDID E496COEC3501200 AB MEDICA	REUSABLE CANNULA TROCAR WITH LOCK TAP D=3.5MM L=120MM COEC350120	2021-08-02
GUDID E496C35HH330 AB MEDICA	C35-Hand Activated HOOK L=330mm C35-HH-33	2021-08-02
GUDID E496LILIP2SC20ST0 AB MEDICA	Low Impact™ Curved Scissors, Jaw Insert (sterile) L=20cm LIL-IP-2SC-20ST	2021-06-21
GUDID E496C35IPSM330 AB MEDICA	C35- SEMM insert 1movable jaws L 33cm D 3,5mm C35-IP-SM-33	2021-04-09
GUDID E496C35IPS20330 AB MEDICA	C35-20mm Tapered insert L 33cm D 3,5mm C35-IP-S20-33	2021-04-09
GUDID E496C35IP2DC330 AB MEDICA	C35-"C" Shape Dissector, Jaw Insert L=33mm D=3,5mm C35-IP-2DC-33	2021-04-09
GUDID E496C35IP2CL330 AB MEDICA	C35-Clutch 2 mobile jaws insert L 33cm D 3,5mm C35-IP-2CL-33	2021-04-09
GUDID E496C35IP2BI330 AB MEDICA	C35-Biopsy 2 mobile jaws insert L 33cm D 3,5mm C35-IP-2BI-33	2021-04-09
GUDID E496C35IP2AL330 AB MEDICA	C35-Allis Grasping Forceps, 2 mobile jaws Insert L=33mm D=3,5mm C35-IP-2AL-33	2021-04-09
GUDID E496C05OPT300 AB MEDICA	HD3 laparoscope, 5.5mm, 30°, autoclavable, HM C05-OPT-30	2020-08-13
GUDID E496C05OPT00 AB MEDICA	HD3 laparoscope, 5.5mm, 0°, autoclavable, HM C05-OPT-0	2020-08-13
GUDID E496C35IBFS330 AB MEDICA	C35-Bipolar Insert L 33cm D 3,5mm C35-IB-FS-33	2020-07-29
GUDID E496C35HBP0 AB MEDICA	C35-Bipolar Handle L 33cm D 3,5mm C35-H-BP	2020-07-29
GUDID E496C35BTU330 AB MEDICA	C35-Bipolar Tube L 33cm D 3,5mm C35-BTU-33	2020-07-29
GUDID E496LILOPT300 AB MEDICA	HD Laparoscope, 3,3mm, 30°, autoclavable LIL-OPT-30	2020-03-25
GUDID E496LILOPT00 AB MEDICA	HD Laparoscope, 3,3mm, 0°, autoclavable LIL-OPT-0	2020-03-25
GUDID E496C35TUSC330 AB MEDICA	C35-Insulated Outer Tube for scissors head L=330mm D=3,5mm C35-TUSC-33	2020-03-11
GUDID E496C35TU330 AB MEDICA	C35-Insulated Outer Tube L=330mm D=3,5mm C35-TU-33	2020-03-11
GUDID E496C35ST2SCST1 AB MEDICA	C35-Curved scissor D3,5mm Sterile C35-ST-2SC-ST	2020-03-11
GUDID E496C35SEAL30 AB MEDICA	Disposable valve for trocar D=3,5mm (x3) C35-SEAL-3	2020-03-11
GUDID E496C35SEAL10 AB MEDICA	Disposable valve for trocar D=3,5mm C35-SEAL-1	2020-03-11
GUDID E496C35SAT20 AB MEDICA	C35-Scalpel accessory tool C35-SAT-2	2020-03-11
GUDID E496C35RS330 AB MEDICA	C35-Rounded Stylus L=330mm D=3,5mm C35-RS-33	2020-03-11
GUDID E496C35PN330 AB MEDICA	C35-Aspiration Needle L=330mm D=3,5mm C35-PN-33	2020-03-11
GUDID E496C35PC330 AB MEDICA	C35-Aspiration Cannula L=330mm D=3,5mm C35-PC-33	2020-03-11
GUDID E496C35NS330 AB MEDICA	C35-Needle Driver - Straight L=330mm D=3,5mm C35-NS-33	2020-03-11
GUDID E496C35KG330 AB MEDICA	C35-Knot Pusher L=330mm D=3,5mm C35-KG-33	2020-03-11
GUDID E496C35IPTG330 AB MEDICA	C35-Tiger insert L=330mm D=3,5mm C35-IP-TG-33	2020-03-11
GUDID E496C35IPTF2330 AB MEDICA	C35-Thin 20mm Fenestrated insert L=330mm D=3,5mm C35-IP-TF2-33	2020-03-11
GUDID E496C35IPS15330 AB MEDICA	C35-15mm Tapered insert L=330mm D=3,5mm C35-IP-S15-33	2020-03-11
GUDID E496C35IPIC330 AB MEDICA	C35-Intestinal clamp insert L=330mm D=3,5mm C35-IP-IC-33	2020-03-11
GUDID E496C35IPF3B330 AB MEDICA	C35-30mm Curved Fenestrated insert L=330mm D=3,5mm C35-IP-F3B-33	2020-03-11
GUDID E496C35IPF30330 AB MEDICA	C35-30mm Fenestrated insert L=330mm D=3,5mm C35-IP-F30-33	2020-03-11
GUDID E496C35IPF15330 AB MEDICA	C35-15mm Fenestrated insert L=330mm D=3,5mm C35-IP-F15-33	2020-03-11
GUDID E496C35IPCO330 AB MEDICA	C35-Cobra insert L=330mm D=3,5mm C35-IP-CO-33	2020-03-11
GUDID E496C35IP2SM330 AB MEDICA	C35-330 mm SEMM insert 2 movable jaws D=3,5mm C35-IP-2SM-33	2020-03-11
GUDID E496C35IP2FS330 AB MEDICA	C35-330mm insert with 2 movable Fenestrated jaws length 15mm D=3,5mm C35-IP-2FS-33	2020-03-11
GUDID E496C35IP2F3330 AB MEDICA	C35-330mm insert with 2 movable Fenestrated jaws length 25mm D=3,5mm C35-IP-2F3-33	2020-03-11
GUDID E496C35IP2F2330 AB MEDICA	C35-330mm insert with 2 movable Fenestrated jaws length 20mm D=3,5mm C35-IP-2F2-33	2020-03-11
GUDID E496C35IP2F1330 AB MEDICA	C35-15mm Fenestrated 2 mobile jaws insert L=330mm D=3,5mm C35-IP-2F1-33	2020-03-11
GUDID E496C35IP2DS330 AB MEDICA	C35-"S" Shape Dissector, Jaw Insert L=330mm D=3,5mm C35-IP-2DS-33	2020-03-11
GUDID E496C35IPF20330 AB MEDICA	C35-20mm Fenestrated insert L=330mm D=3,5mm C35-IP-F20-33	2020-03-10
GUDID E496C35IPCL330 AB MEDICA	C35-Clutch insert L=330mm D=3,5mm C35-IP-CL-33	2020-03-10
GUDID E496C35IPBK330 AB MEDICA	C35-IP-BK-33 C35-IP-BK-33	2020-03-10
GUDID E496C35IPAL330 AB MEDICA	C35-Allis Grasping Forceps, Jaw Insert L=330mm D=3,5mm C35-IP-AL-33	2020-03-10
GUDID E496C35IP2DM330 AB MEDICA	C35-Maryland Dissector, Jaw Insert L=330mm D=3,5mm C35-IP-2DM-33	2020-03-10
GUDID E496C35CT330 AB MEDICA	C35-Monopolar Coagulation Tip L=330mm D=3,5mm C35-CT-33	2020-03-10
GUDID E496C35CH330 AB MEDICA	C35-Classical HOOK L=330mm D=3,5mm C35-CH-33	2020-03-10
GUDID E496LILIPF10310 AB MEDICA	Microlap - 310mm insert with 2 movable Fenestrated jaws length 10mm LIL-IP-F10-31	2019-07-08
GUDID E496LILIPF10200 AB MEDICA	Microlap - 200mm insert with 2 movable Fenestrated jaws length 10mm LIL-IP-F10-20	2019-07-08
GUDID E496C05TUSC500 AB MEDICA	insulated outer tube for scissor head L=50cm D=5mm	2019-05-15
GUDID E496C05TUSC350 AB MEDICA	insulated outer tube for scissor head L=35cm D=5mm	2019-05-15
GUDID E496C05TU500 AB MEDICA	Insulated outer tube L=50cm D=5mm	2019-05-15
GUDID E496C05TU350 AB MEDICA	Insulated outer tube L=35cm D=5mm	2019-05-15
GUDID E496C05RS500 AB MEDICA	MicroLap Rounded Stylus L=50cm D=5mm	2019-05-15
GUDID E496C05RS350 AB MEDICA	MicroLap Rounded Stylus L=35cm D=5mm	2019-05-15
GUDID E496C05PN500 AB MEDICA	MicroLap Aspiration Needle L=50cm D=5mm	2019-05-15
GUDID E496C05PN350 AB MEDICA	MicroLap Aspiration Needle L=35cm D=5mm	2019-05-15
GUDID E496C05PC500 AB MEDICA	MicroLap Aspiration Cannula L=50cm D=5mm	2019-05-15
GUDID E496C05PC350 AB MEDICA	MicroLap Aspiration Cannula L=35cm D=5mm	2019-05-15
GUDID E496C05NS500 AB MEDICA	MicroLap Needle Driver - Straight L=50cm D=5mm	2019-05-15
GUDID E496C05NS350 AB MEDICA	MicroLap Needle Driver - Straight L=35cm D=5mm	2019-05-15
GUDID E496C05LH500 AB MEDICA	MicroLap Monopolar "L" Hook L=50cm D=5mm	2019-05-15
GUDID E496C05LH350 AB MEDICA	MicroLap Monopolar "L" Hook L=35cm D=5mm	2019-05-15
GUDID E496C05KG500 AB MEDICA	MicroLap Knot Pusher L=50cm D=5mm	2019-05-15
GUDID E496C05KG350 AB MEDICA	MicroLap Knot Pusher L=35cm D=5mm	2019-05-15
GUDID E496C05JH500 AB MEDICA	MicroLap Monopolar "J" Hook L=50cm D=5mm	2019-05-15
GUDID E496C05JH350 AB MEDICA	MicroLap Monopolar "J" Hook L=35cm D=5mm	2019-05-15
GUDID E496C05IPTG500 AB MEDICA	Tiger insert L=50cm D=5mm	2019-05-15
GUDID E496C05IPTG350 AB MEDICA	Tiger insert L=35cm D=5mm	2019-05-15
GUDID E496C05CT500 AB MEDICA	MicroLap Monopolar Coagulation Tip L=50cm D=5mm	2019-05-15
GUDID E496C05CT350 AB MEDICA	MicroLap Monopolar Coagulation Tip L=35cm D=5mm	2019-05-15
GUDID E496C05IPS20500 AB MEDICA	20mm Tapered insert L=50cm D=5mm	2019-05-14
GUDID E496C05IPS20350 AB MEDICA	20mm Tapered insert L=35cm D=5mm	2019-05-14
GUDID E496C05IPF3B500 AB MEDICA	30mm curved Fenestrated insert L=50cm D=5mm	2019-05-14
GUDID E496C05IPF3B350 AB MEDICA	30mm curved Fenestrated insert L=35cm D=5mm	2019-05-14
GUDID E496C05IPF30500 AB MEDICA	30mm Fenestrated insert L=50cm D=5mm	2019-05-14
GUDID E496C05IPF30350 AB MEDICA	30mm Fenestrated insert L=35cm D=5mm	2019-05-14
GUDID E496C05IPF20500 AB MEDICA	20mm Fenestrated insert L=50cm D=5mm	2019-05-14
GUDID E496C05IPF20350 AB MEDICA	20mm Fenestrated insert L=35cm D=5mm	2019-05-14
GUDID E496C05IPCU500 AB MEDICA	Biopsy 2 mobile jaws insert L=50cm D=5mm	2019-05-14
GUDID E496C05IPCU350 AB MEDICA	Biopsy 2 mobile jaws insert L=35cm D=5mm	2019-05-14
GUDID E496C05IPBK500 AB MEDICA	Babcock insert L=50cm D=5mm	2019-05-14
GUDID E496C05IPBK350 AB MEDICA	Babcock insert L=35cm D=5mm	2019-05-14
GUDID E496C05IPAL500 AB MEDICA	"Allis" insert L=50cm D=5mm	2019-05-14
GUDID E496C05IPAL350 AB MEDICA	"Allis" insert L=35cm D=5mm	2019-05-14
GUDID E496C05IP2F2500 AB MEDICA	20mm Fenestrated 2 mobile jaws insert L=50cm D=5mm	2019-05-14
GUDID E496C05IP2F2350 AB MEDICA	20mm Fenestrated 2 mobile jaws insert L=35cm D=5mm	2019-05-14
GUDID E496C05IP2DS500 AB MEDICA	"S" shape dissector L=50cm D=5mm	2019-05-14
GUDID E496C05IP2DS350 AB MEDICA	"S" shape dissector L=35cm D=5mm	2019-05-14
GUDID E496C05IP2DM500 AB MEDICA	"Maryland" dissector L=50cm D=5mm	2019-05-14
GUDID E496C05IP2DM350 AB MEDICA	"Maryland" dissector L=35cm D=5mm	2019-05-14
GUDID E496C05IP2DC500 AB MEDICA	"C" shape dissector L=50cm D=5mm	2019-05-14
GUDID E496C05IP2DC350 AB MEDICA	"C" shape dissector L=35cm D=5mm	2019-05-14
GUDID E496C05IP2CL500 AB MEDICA	Clutch 2 mobile jaws insert L=50cm D=5mm	2019-05-14
GUDID E496C05IP2CL350 AB MEDICA	Clutch 2 mobile jaws insert L=35cm D=5mm	2019-05-14
GUDID E496LILIP2SM200 AB MEDICA	Microlap - 200 mm SEMM insert 2 movable jaws	2019-04-10

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• 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 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 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 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 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
• 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 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 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 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 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 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
• 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 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
• 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
• 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
• 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 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
• 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
• 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 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 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
• 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 Medical387 Technology Circle, Nwsuite 500atlanta, GA 30313 PMA NumberP100045 Supplement NumberS063 Date Received08/18/2022 Decision Date09/15/2022 Product Code MOM  Advisory Committee Cardiovascular Clinical TrialsNCT02279888 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
• Abbott Medical15900 Valley View Courtsylmar, CA 91335 PMA NumberP030054 Supplement NumberS402 Date Received08/24/2022 Decision Date09/09/2022 Product Code NIK  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 NumberP910023 Supplement NumberS448 Date Received08/24/2022 Decision Date09/09/2022 Product Code LWS  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 NumberS047 Date Received08/25/2022 Decision Date09/09/2022 Product Code NKM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Medical6901 Preston Roadplano, TX 75024 PMA NumberP010032 Supplement NumberS190 Date Received08/11/2022 Decision Date09/09/2022 Product Code LGW  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Medical6901 Preston Roadplano, TX 75024 PMA NumberP150004 Supplement NumberS057 Date Received05/23/2022 Decision Date08/19/2022 Product Code PMP  Advisory Committee Neurology 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 NumberS046 Date Received07/22/2022 Decision Date08/16/2022 Product Code NKM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Medical177 Country Road B Eastst. Paul, MN 55117 PMA NumberP100009 Supplement NumberS045 Date Received01/31/2022 Decision Date08/08/2022 Product Code NKM  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Medical15900 Valley View Courtsylmar, CA 91335 PMA NumberP960013 Supplement NumberS121 Date Received07/14/2022 Decision Date08/01/2022 Product Code NVN  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 NumberS076 Date Received07/14/2022 Decision Date08/01/2022 Product Code NVN  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 NumberP030054 Supplement NumberS400 Date Received07/14/2022 Decision Date08/01/2022 Product Code NIK  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 NumberS009 Date Received07/01/2022 Decision Date08/01/2022 Product Code NPT  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 NumberP140033 Supplement NumberS074 Date Received07/14/2022 Decision Date08/01/2022 Product Codes NVN LWP  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 NumberP950022 Supplement NumberS143 Date Received07/14/2022 Decision Date08/01/2022 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Medical5050 Nathan Lane Northplymouth, MN 55442 PMA NumberP200049 Supplement NumberS004 Date Received06/16/2022 Decision Date07/28/2022 Product Code NGV  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 NumberP140033 Supplement NumberS073 Date Received07/01/2022 Decision Date07/14/2022 Product Codes LWP NVN  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 NumberP910023 Supplement NumberS446 Date Received07/01/2022 Decision Date07/14/2022 Product Code LWS  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 NumberP030054 Supplement NumberS399 Date Received07/01/2022 Decision Date07/14/2022 Product Code NIK  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 NumberP030035 Supplement NumberS190 Date Received07/01/2022 Decision Date07/14/2022 Product Code NKE  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 NumberP880086 Supplement NumberS324 Date Received07/01/2022 Decision Date07/14/2022 Product Code DXY  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 NumberS008 Date Received06/08/2022 Decision Date07/07/2022 Product Code NPT  Advisory Committee Cardiovascular 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 NumberS078 Date Received06/02/2022 Decision Date06/30/2022 Product Codes PJS NHL MHY  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Medical6901 Preston Roadplano, TX 75024 PMA NumberP010032 Supplement NumberS188 Date Received06/02/2022 Decision Date06/28/2022 Product Code LGW  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Medical6035 Stoneridge Drivepleasanton, CA 94588 PMA NumberP060040 Supplement NumberS086 Date Received04/18/2022 Decision Date06/23/2022 Product Code DSQ  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 NumberP910023 Supplement NumberS445 Date Received05/27/2022 Decision Date06/22/2022 Product Code LWS  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 NumberP910023 Supplement NumberS444 Date Received04/21/2022 Decision Date05/18/2022 Product Code LWS  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 NumberP970013 Supplement NumberS090 Date Received03/07/2022 Decision Date05/17/2022 Product Code LWO  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 NumberS072 Date Received03/07/2022 Decision Date05/17/2022 Product Codes LWP 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 NumberP910023 Supplement NumberS443 Date Received03/07/2022 Decision Date05/17/2022 Product Code LWS  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 NumberP030035 Supplement NumberS189 Date Received03/07/2022 Decision Date05/17/2022 Product Code NKE  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 NumberP030054 Supplement NumberS398 Date Received03/07/2022 Decision Date05/17/2022 Product Code NIK  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 NumberP880086 Supplement NumberS323 Date Received03/07/2022 Decision Date05/17/2022 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 91342 PMA NumberP150035 Supplement NumberS001 Date Received04/18/2022 Decision Date05/04/2022 Product Code LWO  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 NumberS050 Date Received04/06/2022 Decision Date04/26/2022 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 NumberP190023 Supplement NumberS007 Date Received04/18/2022 Decision Date04/20/2022 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 NumberS046 Date Received03/16/2022 Decision Date04/14/2022 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 NumberS049 Date Received03/16/2022 Decision Date04/14/2022 Product Code LWR  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Medical6035 Stoneridge Drivepleasanton, CA 94588 PMA NumberP060040 Supplement NumberS085 Date Received03/14/2022 Decision Date04/11/2022 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 NumberP160054 Supplement NumberS047 Date Received03/14/2022 Decision Date04/11/2022 Product Code DSQ  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 Date Received10/06/2015 Decision Date03/31/2022 Product Code LWO  Advisory Committee Cardiovascular Clinical TrialsNCT01700244 Expedited Review Granted? No
• Abbott Medical6901 Preston Roadplano, TX 75024 PMA NumberP150004 Supplement NumberS056 Date Received02/22/2022 Decision Date03/24/2022 Product Code PMP  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 NumberS076 Date Received02/22/2022 Decision Date03/24/2022 Product Codes PJS MHY NHL  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Medical6901 Preston Roadplano, TX 75024 PMA NumberP010032 Supplement NumberS185 Date Received02/22/2022 Decision Date03/24/2022 Product Code LGW  Advisory Committee Neurology 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 NumberS006 Date Received02/18/2022 Decision Date03/04/2022 Product Code NPT  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Ablecare Medical, Inc.
• ABYS MEDICAL

Related Finance Registrations

NCAGE Code	FB3N3	AB MEDICA
CAGE Code	FB3N3	AB MEDICA