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Device | GORE EXCLUDER AAA ENDOPROSTHESIS |
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 | S081 |
Date Received | 04/02/2013 |
Decision Date | 05/02/2013 |
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 ALTERNATE FEP FILM SUPPLIER AND A CHANGE FROM IN-PROCESS TESTING TO THE RAWMATERIAL TESTING FOR CERTAIN TESTS PERFORMED BY THE NEW QUALIFIED SUPPLIER. |