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.
| Device | Tack Endovascular System (6F) |
| Generic Name | Scaffold, Dissection Repair |
| Applicant | Philips Image Guided Therapy Corporation5905 Nathan Lane Northplymouth, MN 55442 PMA NumberP180034 Supplement NumberS007 Date Received02/23/2022 Decision Date05/24/2022 Product Code QCT Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No |
| Date Received | 2022-02-23 |
| Decision Date | 2022-05-24 |
| PMA | P180034 |
| Supplement | S007 |
| 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 | Philips Image Guided Therapy Corporation 5905 Nathan Lane North plymouth, MN 55442 PMA NumberP180034 Supplement NumberS007 Date Received02/23/2022 Decision Date05/24/2022 Product Code QCT Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement a Change Of Quality Management System And Design Ownership From Intact Vascular, Inc. To Philips Image Guided Therapy Corporation |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00863328000103 | P180034 | 000 |
| 00863328000127 | P180034 | 000 |
| 00863328000110 | P180034 | 000 |
| 00850003494050 | P180034 | 001 |
| 00850003494043 | P180034 | 001 |
| 00850003494036 | P180034 | 001 |