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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.
 
DeviceBiocor, 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 NumberS042
Date Received11/13/2019
Decision Date12/04/2019
Product Code LWR 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Implementation of differential pressure monitoring data loggers for use with the VAISALA Environmental Monitoring System (EMS) at the SJM/Abbott Brazil manufacturing site.
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