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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 ELUMINEXX VASCULAR STENT
Generic NameSTENT, ILIAC
ApplicantBARD PERIPHERAL VASCULAR, INC.
1415 WEST 3RD ST.
TEMPE, AZ 85281
PMA NumberP080007
Supplement NumberS004
Date Received08/12/2010
Decision Date09/08/2010
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  
REVISED FORMULATION FOR THE ADHESIVE USED DURING MANUFACTURING.
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