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: Zilver® Vascular Stent
• Generic Name: STENT, ILIAC
• Applicant: Cook Ireland, Ltd.; O' Halloran Rd., National Technology Park; Limerick
• PMA Number: P050017
• Supplement Number: S022
• Date Received: 08/25/2023
• Decision Date: 09/22/2023
• 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  
Changes to adhesives used in stent delivery systems.