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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 NumberS011
Date Received11/12/2014
Decision Date01/13/2015
Product Code NIU 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol - OSB
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO THE POST-APPROVAL STUDY FOR THE DEVICE TO ALLOW FOR ENROLLMENT OF JAPANESE PMS PATIENTS WITH LESION LENGTH UP TO 200 MM PER LIMB IS COMPLETE.
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