|
Device | Gore TAG Thoracic Stent Graft with ACTIVE CONTROL System |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | W. L. GORE & ASSOCIATES, INC. 3450 KILTIE LANE P.O. BOX 2400 FLAGSTAFF, AZ 86003-2400 |
PMA Number | P040043 |
Supplement Number | S115 |
Date Received | 06/09/2020 |
Decision Date | 07/09/2020 |
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 | No |
Approval Order Statement Implementation of updates to the sleeve trimming procedure and addition of inspection for damage to the deployment line of the GORE TAG Thoracic Stent Graft with ACTIVE CONTROL System. |