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.
Pad printed component supplier change.
| Device | Tack Endovascular System (4F) |
| Generic Name | Scaffold, Dissection Repair |
| Applicant | Intact Vascular, Inc. |
| Date Received | 2020-09-01 |
| Decision Date | 2020-09-28 |
| PMA | P190027 |
| Supplement | S001 |
| Product Code | QCT |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Intact Vascular, Inc. 1285 Drummers Lane, #200 wayne, PA 19087 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P190027 | Original Filing | |
| S005 | 2022-08-29 | Normal 180 Day Track No User Fee |
| S004 | 2022-02-23 | Normal 180 Day Track |
| S003 | ||
| S002 | 2021-09-08 | 30-day Notice |
| S001 | 2020-09-01 | 30-day Notice |