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 NumberS003 Date Received07/26/2022 Decision Date08/05/2022 Product Code MIH Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-07-26 |
| Decision Date | 2022-08-05 |
| PMA | P210032 |
| Supplement | S003 |
| 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 NumberS003 Date Received07/26/2022 Decision Date08/05/2022 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 removal Of Cytotoxicity And Infrared Spectroscopy Inspections For Incoming Components And To Modify The Ovens Used To Manufacture Sidebranch Catheter Assembly |
| 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 |