Approval for the tack endovascular system® (6f, 4. 0-8. 0mm) for use in the superficial femoral and proximal popliteal arteries ranging in diameter from 4. 0mm to 8. 0mm for the repair of post percutaneous transluminal balloon angioplasty dissection(s).
| Device | Tack Endovascular System (6F) |
| Generic Name | Scaffold, Dissection Repair |
| Applicant | Intact Vascular, Inc. |
| Date Received | 2019-08-02 |
| Decision Date | 2020-01-28 |
| PMA | P180034 |
| Supplement | S001 |
| Product Code | QCT |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Intact Vascular, Inc. 1285 Drummers Lane, Suite 200 wayne, PA 19087 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P180034 | | Original Filing |
| S007 |
2022-02-23 |
Normal 180 Day Track |
| S006 | | |
| S005 |
2021-06-10 |
Normal 180 Day Track No User Fee |
| S004 |
2021-02-23 |
30-day Notice |
| S003 |
2020-09-01 |
30-day Notice |
| S002 |
2020-03-17 |
30-day Notice |
| S001 |
2019-08-02 |
Normal 180 Day Track |
NIH GUDID Devices