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Device | GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE |
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 | S055 |
Date Received | 09/16/2013 |
Decision Date | 10/04/2013 |
Product Code |
NIP |
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 USE OF AN ALTERNATE POLYTETRAFLUORO-ETHYLENE (PTFE) RESIN RAW MATERIAL AND AN ALTERNATE MANUFACTURING AID DURING THE OVERWRAP PROCESS. |