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.
Additional verification of the date of manufacture and use by date for devices undergoing rework activities
| Device | IN.PACT AV DCB |
| Generic Name | Drug-coated Peripheral Transluminal Angioplasty Catheter |
| Applicant | Medtronic Vascular Inc. |
| Date Received | 2021-04-23 |
| Decision Date | 2021-05-21 |
| PMA | P190008 |
| Supplement | S014 |
| Product Code | PRC |
| Advisory Committee | Cardiovascular |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |