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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® Vena® Venous Self-Expanding Stent
Generic NameStent, iliac vein
ApplicantCook Ireland, Ltd.
O' Halloran Rd., National Technology Park
Limerick 
PMA NumberP200023
Supplement NumberS009
Date Received03/16/2026
Decision Date04/14/2026
Product Code QAN 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
add Cook Polymer Technology as an additional supplier of the polytetrafluoroethylene tubing used in the delivery system component
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