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Device | GORE® EXCLUDER® AAA Endoprosthesis (AAA) |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | W.L. GORE & ASSOCIATES,INC 32360 N. North Valley Parkway Phoenix, AZ 85085 |
PMA Number | P020004 |
Supplement Number | S192 |
Date Received | 09/06/2022 |
Decision Date | 10/05/2022 |
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 changes to the lot acceptance sampling plan requirements for components that support the sealing cuff of the endoprosthesis. |