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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 W. 3rd St.
Tempe, AZ 85281
PMA NumberP080007
Supplement NumberS013
Date Received04/02/2012
Decision Date04/27/2012
Product Code NIO 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
UPDATES TO EXISTING RAW MATERIAL INSPECTION EQUIPMENT AND THE ADDITION OF NEW RAW MATERIAL INSPECTION EQUIPMENT.
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