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: Cordis® S.M.A.R.T.® CONTROL® Vascular Stent System, Cordis® S.M.A.R.T. RADIANZTM Vascular Stent System
• Generic Name: STENT, ILIAC
• Applicant: Cordis US Corporation; 14201 NW 60th Ave.; Miami Lakes, FL 33014
• PMA Number: P020036
• Supplement Number: S050
• Date Received: 08/31/2023
• Decision Date: 09/28/2023
• Product Code: NIO
• 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  
Updating the Support Member Subassembly process parameters.