Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: GORE VIABAHN ENDOPROSTHESIS (WITH HEPARIN BIOACTIVE SURFACE)
• Classification Name: stent, superficial femoral artery
• Applicant: W.L. GORE & ASSOCIATES,INC
• PMA Number: P040037
• Supplement Number: S023
• Date Received: 08/20/2009
• Decision Date: 09/17/2009
• Product Code: NIP [ Registered Establishments with NIP ]
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Discontinuance of a redundant acceptance activity.