| Device | GORE TAG Thoracic Branch Endoprosthesis (TBE ) |
| Generic Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Applicant | W. L. Gore & Associates, Inc.3450 West Kiltie Laneflagstaff, AZ 86005 PMA NumberP210032 Date Received08/24/2021 Decision Date05/13/2022 Product Code MIH Advisory Committee Cardiovascular Clinical TrialsNCT02777593 Expedited Review Granted? No |
| Date Received | 2021-08-24 |
| Decision Date | 2022-05-13 |
| PMA | P210032 |
| Supplement | S |
| Product Code | MIH |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | W. L. Gore & Associates, Inc. 3450 West Kiltie Lane flagstaff, AZ 86005 PMA NumberP210032 Date Received08/24/2021 Decision Date05/13/2022 Product Code MIH Advisory Committee Cardiovascular Clinical TrialsNCT02777593 Expedited Review Granted? No Combination ProductYes Approval Order Statement Approval For The GORE® TAG® Thoracic Branch Endoprosthesis. The Device Is Intended For Endovascular Repair Of Lesions Of The Descending Thoracic Aorta, While Maintaining Flow Into The Left Subclavian Artery, In Patients Who Are At High Risk For Debranching Subclavian Procedures. Supplements: |
| 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 |