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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 Namevascular stent
PMA NumberP030045
Date Received10/01/2003
Decision Date06/08/2004
Product Code
NIO[ Registered Establishments with NIO ]
Docket Number 04M-0259
Notice Date 06/14/2004
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the intrastent doublestrut stent. The device is indicated for improving luminal diameter in patients with symptomatic atherosclerotic disease of the common and/or external iliac arteries up to 100 mm in length, with a reference vessel diameter of 5 to 10 mm.
Approval Order Approval Order
Supplements: S001 S002