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 NumberS002 Date Received06/22/2022 Decision Date07/21/2022 Product Code MIH Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-06-22 |
| Decision Date | 2022-07-21 |
| PMA | P210032 |
| Supplement | S002 |
| Product Code | MIH |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | W. L. Gore & Associates, Inc. 3450 West Kiltie Lane flagstaff, AZ 86005 PMA NumberP210032 Supplement NumberS002 Date Received06/22/2022 Decision Date07/21/2022 Product Code MIH Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement implementation Of A Pneumatic Sample Cutter And Revised Release And Warning Limits For Heparin Surface Activity Testing |
| 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 |