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 | GORE® TAG® Thoracic Branch Endoprosthesis |
| Generic Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Applicant | W. L. Gore & Associates, Inc.3450 West Kiltie Laneflagstaff, AZ 86005 PMA NumberP210032 Supplement NumberS001 Date Received06/09/2022 Decision Date07/08/2022 Product Code MIH Advisory Committee Cardiovascular Clinical TrialsNCT02777593 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No |
| Date Received | 2022-06-09 |
| Decision Date | 2022-07-08 |
| PMA | P210032 |
| Supplement | S001 |
| Product Code | MIH |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | W. L. Gore & Associates, Inc. 3450 West Kiltie Lane flagstaff, AZ 86005 PMA NumberP210032 Supplement NumberS001 Date Received06/09/2022 Decision Date07/08/2022 Product Code MIH Advisory Committee Cardiovascular Clinical TrialsNCT02777593 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No Combination ProductYes Approval Order Statement Approval Of The Protocol For The Post-approval Study (PAS) Referenced Above. The PAS Protocol Has Been Submitted To Comply With The Conditions Of Approval Outlined In Our Approval Order For P210032. |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P210032 | Original Filing | |
| S005 | 2022-12-15 | 30-day Notice |
| S004 | 2022-09-06 | 30-day Notice |
| S003 | 2022-07-26 | 30-day Notice |
| S002 | 2022-06-22 | 30-day Notice |
| S001 | 2022-06-09 | Normal 180 Day Track No User Fee |