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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.
 
DeviceSJM BIOCOR, BIOCOR SUPRA, EPIC AND EPIC SUPRA HEART VALVES
Generic Nameheart-valve, non-allograft tissue
ApplicantAbbott Medical
177 County Road B. East
St. Paul, MN 55117
PMA NumberP040021
Supplement NumberS011
Date Received08/17/2009
Decision Date10/02/2009
Product Code LWR 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL, WOODRIDGE FACILITY, ST. PAUL, MINNESOTA FOR BIOBURDEN REDUCTION AND CHEMICAL FIXATION OF THE BIOCOR AND EPIC FAMILY OF HEART VALVES.
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