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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 DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS, MODEL 6625 LP & MODEL 6625 ESR-LP
Generic Namereplacement Heart-valve
Regulation Number870.3925
ApplicantEDWARDS LIFESCIENCES, LLC.
One Edwards Way
Irvine, CA 92614
PMA NumberP870077
Supplement NumberS027
Date Received03/24/2008
Decision Date05/23/2008
Withdrawal Date 01/28/2022
Product Code DYE 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
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.
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