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 PTX Drug-Eluting Peripheral Stent.
• Generic Name: Stent, superficial femoral artery, drug-eluting
• Applicant: Cook Ireland, Ltd.; O' Halloran Rd., National Technology Park; Limerick
• PMA Number: P100022
• Supplement Number: S028
• Date Received: 08/01/2018
• Decision Date: 08/29/2018
• Product Code: NIU
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Addition of a delivery system component specification and changes to a supplier's extrusion line.