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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceZilver Flex(R) 35 Vascular Stent
Generic NameSTENT, SUPERFICIAL FEMORAL ARTERY
ApplicantCook Ireland, Ltd.
O' Halloran Rd., National Technology Park
Limerick 
PMA NumberP050017
Supplement NumberS024
Date Received09/27/2024
Decision Date07/01/2025
Product Codes NIO NIP 
Docket Number 25M-2101
Notice Date 07/02/2025
Advisory Committee Cardiovascular
Clinical TrialsNCT00120406
Supplement TypePanel Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
The Zilver Flex® 35 Vascular Stent is intended to improve the luminal diameter in the treatment of de novo or restenotic symptomatic lesions in the native above-the-knee femoropopliteal arteries with reference vessel diameters from 4 to 7 mm and lesion lengths up to 190 mm
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Labeling
Labeling Part 2
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