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 (4F, 1.5-4.5mm) |
| Generic Name | Scaffold, Dissection Repair |
| Applicant | Philips Image Guided Therapy Corporation (formerly Intact)5905 Nathan Lane Northplymouth, MN 55442 PMA NumberP190027 Supplement NumberS005 Date Received08/29/2022 Decision Date11/09/2022 Product Code QCT Advisory Committee Cardiovascular Clinical TrialsNCT02942966 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No |
| Date Received | 2022-08-29 |
| Decision Date | 2022-11-09 |
| PMA | P190027 |
| 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 (formerly Intact) 5905 Nathan Lane North plymouth, MN 55442 PMA NumberP190027 Supplement NumberS005 Date Received08/29/2022 Decision Date11/09/2022 Product Code QCT Advisory Committee Cardiovascular Clinical TrialsNCT02942966 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval For The Post-approval Labeling Update To Include The 36-month Outcomes Of The TOBA II BTK Post-Approval Study. |
| 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 |