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Device | GORE EXCLUDER AAA Endoprosthesis, GORE EXCLUDER Iliac Branch Endoprosthesis (IBE) |
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 | S191 |
Date Received | 08/12/2022 |
Decision Date | 09/13/2022 |
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 updates to the Radio Frequency (RF) bonding process used in the manufacturing of the delivery system for the GORE EXCLUDER AAA Endoprosthesis (AAA) and GORE EXCLUDER Iliac Branch Endoprosthesis (IBE). |