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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 Road
National Technology Park
Limerick 
PMA NumberP100022
Supplement NumberS008
Date Received07/22/2013
Decision Date10/22/2013
Product Code NIU 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR TIGHTENING THE DRUG POTENCY SPECIFICATION AND EXPANSION OF YOUR DEVICE SHELF-LIFE FROM 6 MONTHS TO 12 MONTHS.
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