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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 NameSJM BIOCOR, BIOCOR SUPRA, EPIC AND EPIC SUPRA HEART VALVES
Classification Nameheart-valve, non-allograft tissue
Generic Namereplacement heart valve
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP040021
Supplement NumberS011
Date Received08/17/2009
Decision Date10/02/2009
Product Code
LWR[ Registered Establishments with LWR ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at st. Jude medical, woodridge facility, st. Paul, minnesota for bioburden reduction and chemical fixation of the biocor and epic family of heart valves.
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