Labeling updates which incorporate the final 36-month results from the toba ii post approval study.
| Device | Tack Endovascular System (6F) |
| Generic Name | Scaffold, Dissection Repair |
| Applicant | Philips Image Guided Therapy Corporation |
| Date Received | 2021-06-10 |
| Decision Date | 2021-09-07 |
| PMA | P180034 |
| Supplement | S005 |
| Product Code | QCT |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Pas |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Philips Image Guided Therapy Corporation 5905 Nathan Lane North plymouth, MN 55442 |
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