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.
Approval of the revised study inclusion and exclusion criteria, revised study milestone, and clarification-based updates to the base protocol
| Device | IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter |
| Generic Name | Drug-coated Peripheral Transluminal Angioplasty Catheter |
| Applicant | Medtronic Vascular Inc. |
| Date Received | 2021-01-19 |
| Decision Date | 2021-02-18 |
| PMA | P190008 |
| Supplement | S010 |
| Product Code | PRC |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Ode/oir |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | Medtronic Vascular Inc. 3576 Unocal Place santa Rosa, CA 95403 |
| 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 |