Bolton Medical Inc

FDA Filings

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

FDA Registration(s)

• Registration Number: 2247858
• FEI Number: 1000135961
• Name: BOLTON MEDICAL, INC.
• Owner & Operator: BOLTON MEDICAL, INC.
• Contact Address: 799 INTERNATIONAL PARKWAY --; Sunrise FL 33325 US
• Official Correspondent:
  • Megan A Indeglia
  • x-954-6265122-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 799 International Pkwy ; Sunrise, FL 33325 US
• Establishment Type:
  • Manufacture Device in the United States for Export Only
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 00843576155282 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-28-250-22U	2023-05-03
GUDID 00843576155275 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-28-230-22U	2023-05-03
GUDID 00843576155268 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-28-210-22U	2023-05-03
GUDID 00843576155251 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-28-190-22U	2023-05-03
GUDID 00843576155244 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-28-170-22U	2023-05-03
GUDID 00843576155237 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-28-150-22U	2023-05-03
GUDID 00843576155220 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-28-130-22U	2023-05-03
GUDID 00843576155213 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-28-110-22U	2023-05-03
GUDID 00843576155206 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-28-090-22U	2023-05-03
GUDID 00843576154391 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-26-250-22U	2023-05-03
GUDID 00843576154384 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-26-230-22U	2023-05-03
GUDID 00843576154377 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-26-210-22U	2023-05-03
GUDID 00843576154360 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-26-190-22U	2023-05-03
GUDID 00843576154353 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-26-170-22U	2023-05-03
GUDID 00843576154346 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-26-150-22U	2023-05-03
GUDID 00843576154339 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-26-130-22U	2023-05-03
GUDID 00843576154322 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-26-110-22U	2023-05-03
GUDID 00843576154315 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-26-090-22U	2023-05-03
GUDID 00843576153592 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-24-250-22U	2023-05-03
GUDID 00843576153585 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-24-230-22U	2023-05-03
GUDID 00843576153578 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-24-210-22U	2023-05-03
GUDID 00843576153561 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-24-190-22U	2023-05-03
GUDID 00843576153554 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-24-170-22U	2023-05-03
GUDID 00843576153547 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-24-150-22U	2023-05-03
GUDID 00843576153530 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-24-130-22U	2023-05-03
GUDID 00843576153523 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-24-110-22U	2023-05-03
GUDID 00843576153516 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-24-090-22U	2023-05-03
GUDID 00843576153509 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-250-40U	2023-05-03
GUDID 00843576153493 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-230-40U	2023-05-03
GUDID 00843576153486 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-210-40U	2023-05-03
GUDID 00843576153479 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-190-40U	2023-05-03
GUDID 00843576153462 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-250-38U	2023-05-03
GUDID 00843576153455 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-230-38U	2023-05-03
GUDID 00843576153448 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-210-38U	2023-05-03
GUDID 00843576153431 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-190-38U	2023-05-03
GUDID 00843576153424 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-170-38U	2023-05-03
GUDID 00843576153417 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-250-36U	2023-05-03
GUDID 00843576153400 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-230-36U	2023-05-03
GUDID 00843576153394 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-210-36U	2023-05-03
GUDID 00843576153387 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-190-36U	2023-05-03
GUDID 00843576153370 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-170-36U	2023-05-03
GUDID 00843576153363 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-150-36U	2023-05-03
GUDID 00843576153356 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-250-34U	2023-05-03
GUDID 00843576153349 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-230-34U	2023-05-03
GUDID 00843576153332 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-210-34U	2023-05-03
GUDID 00843576153325 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-190-34U	2023-05-03
GUDID 00843576153318 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-170-34U	2023-05-03
GUDID 00843576153301 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-150-34U	2023-05-03
GUDID 00843576153295 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-250-32U	2023-05-03
GUDID 00843576153288 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-230-32U	2023-05-03
GUDID 00843576153271 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-210-32U	2023-05-03
GUDID 00843576153264 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-190-32U	2023-05-03
GUDID 00843576153257 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-170-32U	2023-05-03
GUDID 00843576153240 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-150-32U	2023-05-03
GUDID 00843576153233 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-130-32U	2023-05-03
GUDID 00843576153226 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-110-32U	2023-05-03
GUDID 00843576153219 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-090-32U	2023-05-03
GUDID 00843576153202 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-250-30U	2023-05-03
GUDID 00843576153196 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-230-30U	2023-05-03
GUDID 00843576153189 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-210-30U	2023-05-03
GUDID 00843576153172 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-190-30U	2023-05-03
GUDID 00843576153165 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-170-30U	2023-05-03
GUDID 00843576153158 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-150-30U	2023-05-03
GUDID 00843576153141 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-130-30U	2023-05-03
GUDID 00843576153134 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-110-30U	2023-05-03
GUDID 00843576153127 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-090-30U	2023-05-03
GUDID 00843576153110 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-250-28U	2023-05-03
GUDID 00843576153103 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-230-28U	2023-05-03
GUDID 00843576153097 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-210-28U	2023-05-03
GUDID 00843576153080 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-190-28U	2023-05-03
GUDID 00843576153073 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-170-28U	2023-05-03
GUDID 00843576153066 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-150-28U	2023-05-03
GUDID 00843576153059 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-130-28U	2023-05-03
GUDID 00843576153042 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-110-28U	2023-05-03
GUDID 00843576153035 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-090-28U	2023-05-03
GUDID 00843576153028 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-250-26U	2023-05-03
GUDID 00843576153011 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-230-26U	2023-05-03
GUDID 00843576153004 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-210-26U	2023-05-03
GUDID 00843576152991 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-190-26U	2023-05-03
GUDID 00843576152984 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-170-26U	2023-05-03
GUDID 00843576152977 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-150-26U	2023-05-03
GUDID 00843576152960 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-130-26U	2023-05-03
GUDID 00843576152953 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-110-26U	2023-05-03
GUDID 00843576152946 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-090-26U	2023-05-03
GUDID 00843576152939 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-250-24U	2023-05-03
GUDID 00843576152922 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-230-24U	2023-05-03
GUDID 00843576152915 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-210-24U	2023-05-03
GUDID 00843576152908 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-190-24U	2023-05-03
GUDID 00843576152892 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-170-24U	2023-05-03
GUDID 00843576152885 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-150-24U	2023-05-03
GUDID 00843576152878 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-130-24U	2023-05-03
GUDID 00843576152861 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-110-24U	2023-05-03
GUDID 00843576152854 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-090-24U	2023-05-03
GUDID 00843576152847 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-230-22U	2023-05-03
GUDID 00843576152830 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-210-22U	2023-05-03
GUDID 00843576152823 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-170-22U	2023-05-03
GUDID 00843576152816 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-130-22U	2023-05-03
GUDID 00843576152809 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-110-22U	2023-05-03
GUDID 00843576149724 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-150-22U	2023-05-03
GUDID 00843576149595 Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System 28-M4-22-090-22U	2023-05-03
PMA P200045S001 Bolton Medical, Inc.	RelayPro Thoracic Stent-Graft System	2021-11-16
PMA P200045 Bolton Medical, Inc.	RelayPro Thoracic Stent-Graft System	2021-08-05
PMA P190015S009 Bolton Medical Inc.	TREO Abdominal Stent-Graft System	2021-04-19
PMA P190015S008 Bolton Medical Inc.	TREO Abdominal Stent-Graft System	2020-12-17
PMA P110038S025 BOLTON MEDICAL, INC.	Relay Thoracic Stent-Graft with Plus Delivery System	2020-12-17
PMA P190015S007 Bolton Medical Inc.	TREO Abdominal Stent-Graft System	2020-12-16
PMA P190015S006 Bolton Medical Inc.	TREO Abdominal Stent-Graft System	2020-10-30
PMA P190015S005 Bolton Medical Inc.	TREO Abdominal Stent-Graft System	2020-10-16
PMA P190015S002 Bolton Medical Inc.	TREO Abdominal Stent-Graft System	2020-08-20
PMA P190015S001 Bolton Medical Inc.	TREO Abdominal Stent-Graft System	2020-07-31
PMA P190015 Bolton Medical Inc.	TREO® Abdominal Stent-Graft System	2020-05-04
PMA P110038S024 BOLTON MEDICAL, INC.	Relay Thoracic Stent-Graft with Plus Delivery System	2019-10-30
PMA P110038S023 BOLTON MEDICAL, INC.	Relay Thoracic Stent-Graft with Plus Delivery System	2019-04-19
PMA P110038S020 BOLTON MEDICAL, INC.	Relay Thoracic Stent-Graft with Plus Delivery System	2018-11-08
PMA P110038S018 BOLTON MEDICAL, INC.	Relay Thoracic Stent-Graft with Plus Delivery System	2018-06-15
PMA P110038S017 BOLTON MEDICAL, INC.	Relay Thoracic Stent-Graft with Plus Delivery System	2018-02-06
PMA P110038S016 BOLTON MEDICAL, INC.	RelayPlus Thoracic Stent-Graft System	2017-12-08
PMA P110038S015 BOLTON MEDICAL, INC.	Relay Thoracic Stent-Graft with Plus Delivery System	2017-05-01
PMA P110038S013 BOLTON MEDICAL, INC.	RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM	2017-03-23
PMA P110038S014 BOLTON MEDICAL, INC.	RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM	2016-10-13
PMA P110038S012 BOLTON MEDICAL, INC.	RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM	2016-09-19
PMA P110038S011 BOLTON MEDICAL, INC.	RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM	2016-04-26
PMA P110038S010 BOLTON MEDICAL, INC.	RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM	2015-11-18
PMA P110038S009 BOLTON MEDICAL, INC.	RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM	2015-03-06
PMA P110038S008 BOLTON MEDICAL, INC.	RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM	2014-12-12
PMA P110038S006 BOLTON MEDICAL, INC.	RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM	2014-09-30
PMA P110038S005 BOLTON MEDICAL, INC.	RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM	2014-06-11
PMA P110038S004 BOLTON MEDICAL, INC.	RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM	2014-04-16
PMA P110038S002 BOLTON MEDICAL, INC.	RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM	2013-07-10
PMN P110038 | MIH BOLTON MEDICAL, INC.	Relay Thoracic Stent-Graft with Plus Delivery System	2012-12-20
PMA P110038S001 BOLTON MEDICAL, INC.	RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM	2012-12-18
PMA P110038 BOLTON MEDICAL, INC.	RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM	2012-09-21
MIH BOLTON MEDICAL, INC.	Treovance Abdominal Stent-Graft with Navitel Delivery System	2007-11-21
MIH BOLTON MEDICAL, INC.	TREO Occluder System	2007-11-21
MIH BOLTON MEDICAL, INC.	TREO Abdominal Stent-Graft System	2007-11-21
MIH BOLTON MEDICAL, INC.	TREO AUI Stent-Graft System	2007-11-21
MIH BOLTON MEDICAL, INC.	RelayPro Thoracic Stent Graft System	2007-11-21
MIH BOLTON MEDICAL, INC.	Relay Thoracic Stent-Graft with Transport Delivery System	2007-11-21
MIH BOLTON MEDICAL, INC.	Relay Plus Thoracic Stent-Graft System	2007-11-21
MIH BOLTON MEDICAL, INC.	Relay NBS Thoracic Stent-Graft with Plus Delivery System	2007-11-21
MIH BOLTON MEDICAL, INC.	Relay NBS Plus Stent -Graft System	2007-11-21
PMN K021996 Bolton Medical, Inc.	BOLTON PTA CATHETER	2002-08-23

Similar & Related FDA Registered Companies

• BOLTON MEDICAL, INC.799 International Parkwaysunrise, FL 33325 PMA NumberP110038 Supplement NumberS027 Date Received12/23/2022 Decision Date01/20/2023 Product Code MIH  Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• Bolton Medical Inc.799 International Pkwysunrise, FL 33325 PMA NumberP190015 Supplement NumberS010 Date Received12/23/2022 Decision Date01/20/2023 Product Code MIH  Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• Bolton Medical, Inc.799 International Parkwaysunrise, FL 33325 PMA NumberP200045 Supplement NumberS003 Date Received07/12/2022 Decision Date08/11/2022 Product Code MIH  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOLTON MEDICAL, INC.799 International Parkwaysunrise, FL 33325 PMA NumberP110038 Supplement NumberS026 Date Received07/12/2022 Decision Date08/11/2022 Product Code MIH  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	8A5S0	BOLTON MEDICAL, INC.
CAGE Code	8A5S0	BOLTON MEDICAL, INC.
S.A.M. Registration	8A5S0 [847424462]	BOLTON MEDICAL, INC.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2018051938802	Barcelona ,Spain -> New York/Newark Area, Newark, New Jersey	VIST LAB MANIQUI SIMULATOR	2 BOX
2018051611133	Barcelona ,Spain -> Port Everglades, Florida	BOLTON MEDICAL QA RECORD	284 BOX
2018051117595	Barcelona ,Spain -> Port Everglades, Florida	BOLTON MEDICAL QA RECORD	284 BOX
2018050524231	Barcelona ,Spain -> Port Everglades, Florida	BOLTON MEDICAL QA RECORD	284 BOX