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: SUPERA PERIPHERAL STENT SYSTEM (SUPERB)
• Generic Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Applicant: Abbott Vascular (Idef Technologies Inc); 3200 Lakeside Dr.; Santa Clara, CA 95054
• PMA Number: P120020
• Supplement Number: S002
• Date Received: 04/08/2014
• Decision Date: 10/20/2014
• Product Code: NIP
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol - OSB
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.