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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameBIOCOR & EPIC VALVES
Classification Nameheart-valve, non-allograft tissue
Generic Namereplacement heart valve
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP040021
Supplement NumberS018
Date Received06/07/2011
Decision Date10/13/2011
Product Code
LWR[ Registered Establishments with LWR ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for a change in the jar set assembly packaging and ethylene oxide sterilization load configuration.
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