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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.
Classification Namestent, iliac
Generic Namestent, iliac
Cook Incorporated
p.o.box 489
bloomington, IN 47402
PMA NumberP050017
Supplement NumberS004
Date Received08/20/2008
Decision Date07/23/2009
Product Code
NIO[ Registered Establishments with NIO ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Recalls CDRH 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.