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Device | GORE EXCLUDER AAA ENDOPROSATHESIS WITH C3 DELIVERY SYSTEM |
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 | S085 |
Date Received | 07/16/2013 |
Decision Date | 08/26/2013 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR REDUCING THE SIZE OF THE SECOND DEPLOYMENT LINE SLIP KNOT LOOP AND A NEW DEPLOYMENT TEST FIXTURE INSERT. |
Post-Approval Study | Show Report Schedule and Study Progress |