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.
An alternate supplier for the tip component of the delivery system
| Device | Tack Endovascular System (4F, 1.5-4.5mm) |
| Generic Name | Scaffold, Dissection Repair |
| Applicant | Philips Image Guided Therapy Corporation (formerly Intact) |
| Date Received | 2021-09-08 |
| Decision Date | 2021-10-08 |
| PMA | P190027 |
| Supplement | S002 |
| 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 | Philips Image Guided Therapy Corporation (formerly Intact) 5905 Nathan Lane North plymouth, MN 55442 |
| 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 |