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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceBARD E-LUMINEXX VASCULAR STENT
Generic NameSTENT, ILIAC
ApplicantBARD PERIPHERAL VASCULAR, INC.
1415 WEST 3RD ST.
TEMPE, AZ 85281
PMA NumberP080007
Supplement NumberS010
Date Received11/14/2011
Decision Date12/07/2011
Product Code NIO 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
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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