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: Duo Venous Stent System
• Generic Name: Stent, iliac vein
• Applicant: Philips Image Guided Therapy Corporation; 5905 Nathan Ln. N.; Plymouth, MN 55442
• PMA Number: P230021
• Supplement Number: S004
• Date Received: 07/27/2026
• Decision Date: 08/26/2026
• Product Code: QAN
• 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  
changes to the nitinol material and supplier