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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 NameST JUDE MEDICAL BIOCOR/BIOCOR/SUPRA/EPIC/EPIC SUPRA HEART VALVES
Classification Nameheart-valve, non-allograft tissue
Generic Namereplacement heart valve
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP040021
Supplement NumberS016
Date Received01/06/2011
Decision Date12/22/2011
Product Code
LWR[ Registered Establishments with LWR ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: packager
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an additional sterilization site and for final packaging operations located at st. Jude medical, pampulha, brazil.
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