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: INNOVA (TM) VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM
• Generic Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Applicant: Boston Scientific Corporation; One Scimed Pl.; Maple Grove, MN 55311
• PMA Number: P140028
• Supplement Number: S001
• Date Received: 08/19/2015
• Decision Date: 09/21/2015
• Product Code: NIP
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR THE POST APPROVAL STUDY PROTOCOL.