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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 VALVE & SUPRA VALVE
Generic Nameheart-valve, non-allograft tissue
ApplicantAbbott Medical
177 County Road B. East
St. Paul, MN 55117
PMA NumberP040021
Supplement NumberS007
Date Received07/31/2008
Decision Date09/26/2008
Product Code LWR 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE SJM BIOCOR 25MM MITRAL VALVE SIZE AND THE EPIC 25 MM MITRAL VALVE SIZE.
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