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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
1415 west 3rd st.
tempe, AZ 85281
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
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S003 S004 S005 S007 S008 S009 S010 S011 
S013 S014 S015 S016 S017 S018 S019 S020