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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 & BIOCOR SUPRA VALVES, EPIC & EPIC SUPRA VALVES
Classification Nameheart-valve, non-allograft tissue
Generic Namereplacement heart valve
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP040021
Supplement NumberS021
Date Received03/22/2012
Decision Date04/13/2012
Product Code
LWR[ Registered Establishments with LWR ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for revising the instruction regarding suture tails.
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