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Device | GORE VIABAHN ENDOPROSTHESIS |
Generic Name | STENT, SUPERFICIAL FEMORAL ARTERY |
Applicant | W.L. GORE & ASSOCIATES,INC 3450 WEST KILTIE LN. P.O. BOX 500 FLAGSTAFF, AZ 86002-0500 |
PMA Number | P040037 |
Supplement Number | S013 |
Date Received | 12/09/2008 |
Decision Date | 06/25/2009 |
Product Code |
NIP |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO MODIFY THE DESIGN PLATFORM OF THE LARGE DIAMETER DEVICE (9-13MM DIAMETER) SO THAT IT IS IDENTICAL TO THE CURRENTLY APPROVED SMALLER DIAMETER DEVICES. THE DESIGN PLATFORM MODIFICATION INCLUDES CHANGES TO THE DELIVERY SYSTEM AND ASSOCIATED MANUFACTURING CHANGES. |