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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® 35 Vascular Stent
Generic NameSTENT, ILIAC
ApplicantCook Ireland, Ltd.
O' Halloran Rd., National Technology Park
Limerick 
PMA NumberP050017
Supplement NumberS025
Date Received09/26/2025
Decision Date10/22/2025
Product Code NIO 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
requested updates to your device labeling, including the graphics, operating principles, precautions and procedural instructions
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