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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameZILVER VASCULAR STENT AND ZILVER VASCULAR STENT WITH RAPID EXCHANGE DELIVERY SYSTEM
Classification Namestent, iliac
ApplicantCOOK INCORPORATED
PMA NumberP050017
Supplement NumberS006
Date Received04/04/2011
Decision Date07/05/2011
Product Code
NIO[ Registered Establishments with NIO ]
Advisory Committee Cardiovascular
Clinical Trials NCT00196066
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
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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