IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter

FDA Premarket Approval P190008 S013

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

The implementation of new product label and component verification software for use on manufacturing lines in medtronic ireland

DeviceIN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter
Generic NameDrug-coated Peripheral Transluminal Angioplasty Catheter
ApplicantMedtronic Vascular Inc.
Date Received2021-03-04
Decision Date2021-03-12
PMAP190008
SupplementS013
Product CodePRC 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address Medtronic Vascular Inc. 3576 Unocal Place santa Rosa, CA 95403

Supplemental Filings

Supplement NumberDateSupplement Type
P190008Original Filing
S022 2022-11-29 30-day Notice
S021 2022-10-31 30-day Notice
S020 2022-09-29 30-day Notice
S019 2022-06-28 30-day Notice
S018 2022-02-04 Normal 180 Day Track No User Fee
S017 2021-11-12 30-day Notice
S016 2021-06-21 30-day Notice
S015
S014 2021-04-23 Special (immediate Track)
S013 2021-03-04 30-day Notice
S012
S011 2021-02-25 30-day Notice
S010 2021-01-19 Normal 180 Day Track No User Fee
S009 2021-01-19 30-day Notice
S008 2020-11-23 30-day Notice
S007
S006 2020-10-02 30-day Notice
S005 2020-08-12 Normal 180 Day Track No User Fee
S004 2020-06-26 Real-time Process
S003 2020-05-28 Normal 180 Day Track No User Fee
S002 2020-01-23 30-day Notice
S001

NIH GUDID Devices

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