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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 AND ZILVER VASCULAR STENT WITH RAPID EXCHANGE DELIVERY SYSTEM
Generic NameSTENT, ILIAC
ApplicantCook Ireland, Ltd.
O'Halloran Road
National Technology Park
Limerick 
PMA NumberP050017
Supplement NumberS006
Date Received04/04/2011
Decision Date07/05/2011
Product Code NIO 
Advisory Committee Cardiovascular
Clinical TrialsNCT00196066
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A PRODUCT LINE EXTENSION THAT REPRESENTS MODIFICATIONS TO THE 6FR VERSION OF THE ZILVER VASCULAR STENT. IN ADDITION, APPROVAL OF MINOR CHANGES TO THE STENT AND DELIVERY SYSTEM AND THE ADDITION OF A 100 MM LENGTH STENT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ZILVER FLEX 35 VASCULAR STENT 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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