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.
| Device | IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter |
| Generic Name | Drug-coated Peripheral Transluminal Angioplasty Catheter |
| Applicant | 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 |
| Date Received | 2022-02-04 |
| Decision Date | 2022-03-04 |
| PMA | P190008 |
| Supplement | S018 |
| Product Code | PRC |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | Medtronic Vascular Inc. 3576 Unocal Place santa 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 Combination ProductYes Approval Order Statement approval Of The Revised Protocol For The Post-approval Study (PAS) Referenced Above. The PAS Protocol Has Been Submitted To Comply With The Conditions Of Approval Outlined In Our Approval Order For P190008 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P190008 | Original 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 |