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: S030
• Date Received: 10/09/2018
• Decision Date: 12/20/2018
• Product Code: NIU
• Advisory Committee: Cardiovascular
• Clinical Trials: NCT00120406
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Labeling Change - PAS
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval to update the labeling to include post-approval study clinical data.