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

FDA Premarket Approval P190008 S021

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

DeviceIN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter
Generic NameDrug-coated Peripheral Transluminal Angioplasty Catheter
ApplicantMedtronic 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
Date Received2022-10-31
Decision Date2022-11-01
PMAP190008
SupplementS021
Product CodePRC 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductYes
Applicant AddressMedtronic Vascular Inc.
3576 Unocal Place
santa 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 Combination ProductYes Approval Order Statement  
the Automation Of A Verification Step Undertaken By Sterile Release Personnel (SRP) For Limulus Amebocyte Lysate (LAL) Bacterial Endotoxin Testing (BET) Prior To Final Release Of Product

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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