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Device | GORE® TAG® Thoracic Branch Endoprosthesis (Side Branch Component only) |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | W. L. Gore & Associates, Inc. 3450 West Kiltie Lane Flagstaff, AZ 86005 |
PMA Number | P210032 |
Supplement Number | S010 |
Date Received | 06/27/2023 |
Decision Date | 07/05/2023 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Implementation of an alternate supplier of the outer foil packaging of the following devices: GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface, GORE VIABAHN VBX Balloon Expandable Endoprosthesis and GORE TAG Thoracic Branch Endoprosthesis. |