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.
The use of an electronic manufacturing execution system (mes) to replace the current paper-based device history record (dhr)
| Device | IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter |
| Generic Name | Drug-coated Peripheral Transluminal Angioplasty Catheter |
| Applicant | Medtronic Vascular Inc. |
| Date Received | 2021-02-25 |
| Decision Date | 2021-03-02 |
| PMA | P190008 |
| Supplement | S011 |
| Product Code | PRC |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| 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 |