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: COMPLETE SE VASCULAR STENT SYSTEM
• Generic Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Applicant: Medtronic Vascular; 3576 Unocal Pl.; Santa Rosa, CA 95403
• PMA Number: P110040
• Supplement Number: S007
• Date Received: 06/15/2015
• Decision Date: 02/25/2016
• Withdrawal Date: 05/23/2019
• Product Code: NIP
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Labeling Change - PAS
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for updating the labeling to include the post-approval study results.