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: S020
• Date Received: 07/05/2016
• Decision Date: 12/28/2016
• Product Code: NIU
• Docket Number: 16M-4653
• Notice Date: 01/03/2017
• Advisory Committee: Cardiovascular
• Clinical Trials: NCT00120406
• Supplement Type: Panel Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for the Zilver PTX Drug-Eluting Peripheral Stent is indicated for improving luminal diameter for the treatment of de novo or restenotic symptomatic lesions in native vascular disease of the above-the-knee femoropopliteal arteries having reference vessel diameter from 4 mm to 7 mm and total lesion lengths up to 300 mm per patient.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2