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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.
 
Trade NameBARD E-LUMINEXX VASCULAR STENT
Classification Namestent, iliac
Generic Nameiliac stent
ApplicantBARD PERIPHERAL VASCULAR, INC.
PMA NumberP080007
Supplement NumberS010
Date Received11/16/2011
Decision Date12/07/2011
Product Code
NIO[ Registered Establishments with NIO ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The surface treatment of the stent to be performed at an alternate supplier and the addition of several optimizations to the process flow.
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