Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• 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: S042
• Date Received: 05/01/2012
• Decision Date: 05/30/2012
• Product Code: NIP
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
CHANGE TO THE AUTOMATED MANUFACTURING AND TESTING DOCUMENTATION PROCESS.