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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 NumberS031
Date Received10/11/2018
Decision Date11/08/2018
Product Code NIU 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Extension to the raw material retest period.
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