Medtronic Vascular Inc

FDA Filings

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

FDA Registration(s)

FDA Filings

Device Company	Device	Date
GUDID 00763000645182 MEDTRONIC VASCULAR, INC.	Heli-FX™ Ancillary EndoAnchor™ Cassette	2022-10-31
GUDID 00763000645175 MEDTRONIC VASCULAR, INC.	Heli-FX™ Thoracic EndoAnchor™ System	2022-10-31
GUDID 00763000645168 MEDTRONIC VASCULAR, INC.	Heli-FX™ Thoracic EndoAnchor™ System	2022-10-31
GUDID 00763000645151 MEDTRONIC VASCULAR, INC.	Heli-FX™ Thoracic EndoAnchor™ System	2022-10-31
GUDID 00763000645144 MEDTRONIC VASCULAR, INC.	Heli-FX™ Thoracic EndoAnchor™ System	2022-10-31
GUDID 00763000645137 MEDTRONIC VASCULAR, INC.	Heli-FX™ EndoAnchor™ System	2022-10-31
PMA P140018S031 MEDTRONIC VASCULAR INC	VenaSeal Closure System	2022-02-17
PMA P200026S004 Medtronic Vascular, Inc.	Abre Venous Self-expanding Stent System	2022-02-11
PMA P110023S033 MEDTRONIC VASCULAR INC	EverFlex™ Self-Expanding Peripheral Stent System, EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery Syste	2022-01-11
PMA P190008S017 Medtronic Vascular Inc.	IN.PACT® AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter	2021-12-09
PMA P140018S030 MEDTRONIC VASCULAR INC	VenaSeal Closure System	2021-12-09
PMA P200026S003 Medtronic Vascular, Inc.	Abre Venous self-expanding stent system	2021-11-05
PMA P140018S028 MEDTRONIC VASCULAR INC	VenaSeal Closure System	2021-10-06
PMA P190008S016 Medtronic Vascular Inc.	IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter	2021-07-21
PMA P200026S002 Medtronic Vascular, Inc.	Abre Venous Self-expanding Stent System	2021-07-09
PMA P190008S014 Medtronic Vascular Inc.	IN.PACT AV DCB	2021-05-21
PMA P140018S025 MEDTRONIC VASCULAR INC	Venaseal Closure System	2021-05-21
PMA P200026S001 Medtronic Vascular, Inc.	Abre Venous Self-expanding Stent System	2021-05-07
PMA P110023S032 MEDTRONIC VASCULAR INC	EverFlex Self-Expanding Peripheral Stent System, EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System	2021-05-07
PMA P060001S032 MEDTRONIC VASCULAR INC	Protégé RX Self-expanding Stent System, Protégé GPS Self-Expanding Peripheral Stent System	2021-05-07
PMA P030045S006 MEDTRONIC VASCULAR INC	lntraStent DoubleStrut Stent, Visi-Pro Balloon-Expandable Peripheral Stent System	2021-05-07
PMA P190008S013 Medtronic Vascular Inc.	IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter	2021-03-12
PMA P190008S011 Medtronic Vascular Inc.	IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter	2021-03-02
PMA P140018S023 MEDTRONIC VASCULAR INC	VenaSeal Closure System	2021-03-02
PMA P190008S010 Medtronic Vascular Inc.	IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter	2021-02-18
PMA P190008S009 Medtronic Vascular Inc.	IN.PACT AV Paclitaxel-Coated PTA Balloon Catheter	2021-02-04
PMA P140018S021 MEDTRONIC VASCULAR INC	VenaSeal Closure System	2021-01-21
PMA P110023S031 MEDTRONIC VASCULAR INC	EverFlex Self-Expanding Peripheral Stent System, EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System	2021-01-04
PMA P060001S031 MEDTRONIC VASCULAR INC	Protege GPS Self-Expanding Peripheral Stent System	2021-01-04
PMA P190008S008 Medtronic Vascular Inc.	IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter	2020-11-24
PMA P200026 Medtronic Vascular, Inc.	Abre Venous Self-expanding Stent System	2020-10-21
PMA P190008S006 Medtronic Vascular Inc.	IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter	2020-10-14
PMA P190008S004 Medtronic Vascular Inc.	IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter	2020-09-24
PMA P140018S020 MEDTRONIC VASCULAR INC	VenaSeal Closure System	2020-09-21
PMA P190008S005 Medtronic Vascular Inc.	IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter	2020-09-11
PMA P110023S030 MEDTRONIC VASCULAR INC	EverFlex Self-Expanding Peripheral Stent System	2020-08-18
PMA P060001S030 MEDTRONIC VASCULAR INC	Protégé GPS Self-Expanding Peripheral Stent System	2020-08-18
PMA P110023S029 MEDTRONIC VASCULAR INC	EverFlex Self-expanding Peripheral Stent System (SFA/PPA) and EverFlex Self-expanding Peripheral Stent System (iliac)	2020-08-04
PMA P060001S029 MEDTRONIC VASCULAR INC	Protege GPS Self-expanding Peripheral Stent System	2020-08-04
PMA P190008S003 Medtronic Vascular Inc.	IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter	2020-06-25
GUDID 00643169647695 MEDTRONIC VASCULAR, INC.	APTUS Heli-FX®	2020-05-06
GUDID 00643169647664 MEDTRONIC VASCULAR, INC.	APTUS Heli-FX®	2020-05-06
GUDID 00643169647640 MEDTRONIC VASCULAR, INC.	APTUS Heli-FX®	2020-05-06
GUDID 00643169647626 MEDTRONIC VASCULAR, INC.	APTUS Heli-FX®	2020-05-06
GUDID 00643169647602 MEDTRONIC VASCULAR, INC.	APTUS Heli-FX®	2020-05-06
GUDID 00643169647572 MEDTRONIC VASCULAR, INC.	APTUS Heli-FX®	2020-05-06
GUDID 00643169647565 MEDTRONIC VASCULAR, INC.	APTUS Heli-FX®	2020-05-06
PMA P140018S019 MEDTRONIC VASCULAR INC	VenaSeal Closure System	2020-04-10
PMA P190008S002 Medtronic Vascular Inc.	In.Pact AV Paclitaxel-Coated PTA Balloon Catheter	2020-02-20
PMA P140018S018 MEDTRONIC VASCULAR INC	VenaSeal Closure System	2020-01-25
PMA P140018S017 MEDTRONIC VASCULAR INC	VenaSeal Closure System	2019-12-20
PMA P190008 Medtronic Vascular Inc.	IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter	2019-11-21
PMA P110023S028 MEDTRONIC VASCULAR INC	EverFlex Self-Expanding Peripheral Stent Systems and EverFlex Self-Expanding Peripheral Stent with Entrust Delivery Syst	2019-11-20
PMA P140018S016 MEDTRONIC VASCULAR INC	VenaSeal Closure System	2019-08-12
PMA P140018S015 MEDTRONIC VASCULAR INC	VenaSeal Closure System	2019-06-19
PMA P110023S027 MEDTRONIC VASCULAR INC	EverFlex Self-Expanding Peripheral Stent Systems and EverFlex Self-Expanding Peripheral Stent with Entrust Delivery Syst	2019-06-17
PMA P060001S028 MEDTRONIC VASCULAR INC	Protégé GPS and Protégé RX Carotid Stent Systems, and Protégé GPS Peripheral Stent Systems	2019-06-17
PMA P110023S026 MEDTRONIC VASCULAR INC	EverFlex Self-Expanding Peripheral Stent Systems and EverFlex Self-Expanding peripheral Stent with Entrust Delivery Syst	2019-05-23
PMA P060001S027 MEDTRONIC VASCULAR INC	Protege RX Carotid Stent Systems and Protege GPS Peripheral Stent Systems	2019-05-23
PMA P030045S005 MEDTRONIC VASCULAR INC	Visi-Pro Balloon-Expandable Peripheral Stent System	2019-05-23
PMA P110023S025 MEDTRONIC VASCULAR INC	EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System	2019-03-21
PMA P140018S014 MEDTRONIC VASCULAR INC	Venaseal Closure System	2018-12-07
PMN K182957 Medtronic Vascular, Inc.	Heli-FX EndoAnchor System	2018-11-21
PMA P140018S013 MEDTRONIC VASCULAR INC	Venaseal Closure System	2018-10-05
PMA P140018S012 MEDTRONIC VASCULAR INC	VenaSeal Closure System	2018-09-06
PMA P140018S011 MEDTRONIC VASCULAR INC	VenaSeal Closure System	2018-04-24
PMA P140018S010 MEDTRONIC VASCULAR INC	VenaSeal Closure System	2018-04-03
PMA P140018S009 MEDTRONIC VASCULAR INC	VenaSeal Closure System	2018-03-27
PMA P140018S008 MEDTRONIC VASCULAR INC	VenaSeal Closure System	2018-01-30
PMN K171866 Medtronic Vascular, Inc.	Sentrant Introducer Sheath With Hydrophilic Coating	2017-12-20
PMA P110023S024 MEDTRONIC VASCULAR INC	EverFlex Self-Expanding Peripheral Stent System; EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System;	2017-11-27
PMA P060001S026 MEDTRONIC VASCULAR INC	Protege GPS and Protege RX Carotid Stent System; Protege GPS Self-expanding Peripheral Stent System (Iliac)	2017-11-27
PMA P030045S004 MEDTRONIC VASCULAR INC	IntraStent DoubleStrut Stent; Visi-Pro Balloon-Expandable Peripheral Stent System (Ilac)	2017-11-27
PMA P140018S006 MEDTRONIC VASCULAR INC	VenaSeal Closure System	2017-08-22
PMA P140018S007 MEDTRONIC VASCULAR INC	VenaSeal Closure System	2017-07-13
PMN K170191 MEDTRONIC VASCULAR, INC.	SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System	2017-06-16
PMN K171427 Medtronic Vascular, Inc.	Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette	2017-06-13
PMA P110023S023 MEDTRONIC VASCULAR INC	EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM	2016-12-14
PMA P140018S005 MEDTRONIC VASCULAR INC	VENASEAL CLOSURE SYSTEM	2016-12-01
PMA P110023S022 MEDTRONIC VASCULAR INC	EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX)	2016-11-25
PMA P110023S021 MEDTRONIC VASCULAR INC	EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX)	2016-11-23
PMA P140018S004 MEDTRONIC VASCULAR INC	VENASEAL CLOSURE SYSTEM	2016-10-21
PMN K161361 Medtronic Vascular, Inc.	HawkOne Directional Atherectomy System	2016-10-14
PMA P140018S003 MEDTRONIC VASCULAR INC	VENASEAL CLOSURE SYSTEM	2016-08-21
PMA P110023S020 MEDTRONIC VASCULAR INC	EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM ,EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM	2016-08-02
PMA P140018S002 MEDTRONIC VASCULAR INC	VENASEAL CLOSURE SYSTEM	2016-07-27
PMA P110023S019 MEDTRONIC VASCULAR INC	EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX)	2016-06-22
PMA P110023S018 MEDTRONIC VASCULAR INC	EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX)	2016-04-20
PMA P110023S016 MEDTRONIC VASCULAR INC	EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM	2015-12-17
PMA P060001S024 MEDTRONIC VASCULAR INC	PROTEGE GPS STENT SYSTEM	2015-12-14
PMA P140018S001 MEDTRONIC VASCULAR INC	VENASEAL CLOSURE SYSTEM	2015-10-07
PMA P110023S015 MEDTRONIC VASCULAR INC	EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM	2015-06-24
PMA P110023S012 MEDTRONIC VASCULAR INC	EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM	2015-04-29
PMA P030045S002 MEDTRONIC VASCULAR INC	INTRASTENT DOUBLESTRUT STENT	2015-04-16
PMA P110023S014 MEDTRONIC VASCULAR INC	EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM	2015-04-02
PMA P060001S023 MEDTRONIC VASCULAR INC	PROTEGE GPS CAROTID STENT SYSTEM, PROTEGE GPS SELF-EXPANDING PERIPHERAL STENT SYSTEM	2015-04-02
PMA P140018 MEDTRONIC VASCULAR INC	VENASEAL CLOSURE SYSTEM	2015-02-20
PMA P060001S020 MEDTRONIC VASCULAR INC	PROTEGE GPS SELF EXPANDING PERIPHERAL STENT SYSTEM	2015-01-21
PMA P110023S013 MEDTRONIC VASCULAR INC	EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM	2014-12-10
PMA P110023S007 MEDTRONIC VASCULAR INC	EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM	2014-10-10
PMA P110023S010 MEDTRONIC VASCULAR INC	EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM	2014-09-03
PMA P110023S011 MEDTRONIC VASCULAR INC	EVERFLEX SELF EXPANDING PERIPHERAL STENT SYSTEM	2014-08-20
PMA P060001S022 MEDTRONIC VASCULAR INC	PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEM	2014-08-20

Similar & Related FDA Registered Companies

Medtronic Vascular, Inc.(formerly Ev3 Inc.)
MEDTRONIC VASCULAR INC3033 Campus Driveplymouth, MN 55441 PMA NumberP060001 Supplement NumberS035 Date Received11/15/2022 Decision Date12/15/2022 Product Code NIM Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
MEDTRONIC VASCULAR INC3033 Campus Driveplymouth, MN 55441 PMA NumberP110023 Supplement NumberS036 Date Received11/15/2022 Decision Date12/15/2022 Product Code NIP Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
MEDTRONIC VASCULAR INC3033 Campus Driveplymouth, MN 55441 PMA NumberP140018 Supplement NumberS036 Date Received11/29/2022 Decision Date12/01/2022 Product Code PJQ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Medtronic Vascular Inc.3576 Unocal Placesanta Rosa, CA 95403 PMA NumberP190008 Supplement NumberS022 Date Received11/29/2022 Decision Date12/01/2022 Product Code PRC Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
MEDTRONIC VASCULAR INC3033 Campus Driveplymouth, MN 55441 PMA NumberP140018 Supplement NumberS035 Date Received10/12/2022 Decision Date11/08/2022 Product Code PJQ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Medtronic Vascular Inc.3576 Unocal Placesanta Rosa, CA 95403 PMA NumberP190008 Supplement NumberS021 Date Received10/31/2022 Decision Date11/01/2022 Product Code PRC Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Medtronic Vascular Inc.3576 Unocal Placesanta Rosa, CA 95403 PMA NumberP190008 Supplement NumberS020 Date Received09/29/2022 Decision Date10/11/2022 Product Code PRC Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
MEDTRONIC VASCULAR INC3033 Campus Driveplymouth, MN 55441 PMA NumberP140018 Supplement NumberS034 Date Received08/15/2022 Decision Date09/13/2022 Product Code PJQ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
MEDTRONIC VASCULAR INC3033 Campus Driveplymouth, MN 55441 PMA NumberP140018 Supplement NumberS032 Date Received04/29/2022 Decision Date07/27/2022 Product Code PJQ Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
Medtronic Vascular, Inc.3033 Campus Driveplymouth, MN 55441 PMA NumberP200026 Supplement NumberS005 Date Received06/17/2022 Decision Date07/22/2022 Product Code QAN Advisory Committee Cardiovascular Clinical TrialsNCT03038438 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No
Medtronic Vascular Inc.3576 Unocal Placesanta Rosa, CA 95403 PMA NumberP190008 Supplement NumberS019 Date Received06/28/2022 Decision Date07/08/2022 Product Code PRC Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
MEDTRONIC VASCULAR INC3033 Campus Driveplymouth, MN 55441 PMA NumberP110023 Supplement NumberS035 Date Received05/25/2022 Decision Date06/03/2022 Product Code NIP Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
MEDTRONIC VASCULAR INC3033 Campus Driveplymouth, MN 55441 PMA NumberP060001 Supplement NumberS034 Date Received05/25/2022 Decision Date06/03/2022 Product Code NIM Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
MEDTRONIC VASCULAR INC3033 Campus Driveplymouth, MN 55441 PMA NumberP060001 Supplement NumberS033 Date Received03/29/2022 Decision Date05/23/2022 Product Code NIM Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
Medtronic Vascular Inc.3576 Unocal Placesanta Rosa, CA 95403 PMA NumberP190008 Supplement NumberS018 Date Received02/04/2022 Decision Date03/04/2022 Product Code PRC Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No

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