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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 NumberS005
Date Received04/20/2011
Decision Date09/02/2011
Product Code
NIO[ Registered Establishments with NIO ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for two changes to the validated eto sterilization cycle (#14) chamber pressure parameters, for the device.
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