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 Vascular Self Expanding Stent System
• Generic Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Applicant: Boston Scientific Corporation; One Scimed Pl.; Maple Grove, MN 55311
• PMA Number: P140028
• Supplement Number: S046
• Date Received: 09/30/2019
• Decision Date: 10/07/2019
• Product Code: NIP
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Expansion of your manufacturing clean room.