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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 VASCULAR STENT
Generic NameSTENT, ILIAC
ApplicantCook Ireland, Ltd.
O'Halloran Road
National Technology Park
Limerick 
PMA NumberP050017
Supplement NumberS004
Date Received08/20/2008
Decision Date07/23/2009
Product Code NIO 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR A MODIFICATION FROM THE EXISTING OVER-THE-WIRE DELIVERY SYSTEM TO A RAPID EXCHANGE DELIVERY SYSTEM FOR THE DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ZILVER VASCULAR STENT WITH RAPID EXCHANGE DELIVERY SYSTEM AND IS INDICATED FOR USE AS AN ADJUNCT TO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) IN THE TREATMENT OF SYMPTOMATIC VASCULAR DISEASE OF THE ILIAC ARTERIES UP TO 100 MM IN LENGTH, WITH A REFERENCE VESSEL DIAMETER OF 5 TO 9 MM. PATIENTS MUST BE SUITABLE FOR PTA AND STENT TREATMENT.
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