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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namestent, iliac
Generic Namestent, iliac
Cook Incorporated
p.o.box 489
bloomington, IN 47402
PMA NumberP050017
Date Received04/15/2005
Decision Date06/26/2006
Product Code
NIO[ Registered Establishments with NIO ]
Docket Number 06M-0294
Notice Date 07/26/2006
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the zilver vascular stent. This device 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.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S008 S009 S010 
S011 S012 S013