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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 NumberS006
Date Received06/19/2013
Decision Date07/19/2013
Product Code NIU 
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  
APPROVAL FOR MODIFICATIONS TO THE INSTRUCTIONS FOR USE (IFU) TO IMPROVE CLARITY BY PROVIDING RECOMMENDATIONS FOR APPROPRIATE GUIDEWIRE SELECTION AND ADDITIONAL INSTRUCTIONS FOR WHEN RESISTANCE IS ENCOUNTERED DURING CATHETER USE.
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