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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® PTX® Drug-Eluting Peripheral Stent
Generic NameStent, superficial femoral artery, drug-eluting
ApplicantCook Ireland, Ltd.
O' Halloran Rd., National Technology Park
Limerick 
PMA NumberP100022
Supplement NumberS038
Date Received08/11/2021
Decision Date11/02/2021
Product Code NIU 
Advisory Committee Cardiovascular
Clinical TrialsNCT01901289
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the addition of the US ZILVER PTX POST-APPROVAL STUDY 2 (PAS 2) results to the Instructions for Use
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