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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.
 
DeviceCARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL BIOPROSTHESIS, MODEL 7000 AND 7000TFX
Generic Namereplacement Heart-valve
Regulation Number870.3925
ApplicantEDWARDS LIFESCIENCES, LLC.
One Edwards Way
Irvine, CA 92614
PMA NumberP860057
Supplement NumberS051
Date Received11/28/2008
Decision Date01/27/2009
Product Code DYE 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO EXTEND THE USE OF THE SENSITECH TAGALERT TEMPERATURE ALARM INDICATOR ON THE DEVICE PACKAGING FROM TRANSIT ONLY TO BOTH TRANSIT AND STORAGE UP TO FOUR (4) YEARS, AND FOR A NEW CARTON FOR THE EXISTING 3.8 OZ JAR AND ITS ACCOMPANYING PACKAGING SYSTEMS, AND ASSOCIATED LABELING.
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