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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 Nameiliac stent
PMA NumberP080007
Date Received03/21/2008
Decision Date12/04/2008
Product Code
NIO[ Registered Establishments with NIO ]
Docket Number 08M-0645
Notice Date 12/19/2008
Advisory Committee Cardiovascular
Clinical Trials NCT00561457
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the bard e. Luminexx vasular stent. The device is indicated for the treatment f iliac occlusive disease in patients with symptomatic vascular disease of the common and/or external iliac arteries up to 126 mm in length, with a reference vessel diameter of 5 to 9 mm.
Approval Order Approval Order
Supplements: S001 S003 S004 S005 S007 S008 S009 S010 S011 
S013 S014 S015 S016 S017 S018 S019 S020