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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 VALVE AND SJM BIOCOR SUPRA VALVE
Classification Nameheart-valve, non-allograft tissue
Generic Namereplacement heart valve
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP040021
Supplement NumberS003
Date Received08/07/2006
Decision Date05/25/2007
Product Code
LWR[ Registered Establishments with LWR ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of the 29mm biocor aortic valve; addition of sizes 25mm and 27mm bicor supra aortic valve; a change in the package solution concentration; a reduced pre-implant rinse time; a change in the vale holder and holder handle designs; and additional hemodynamic data for the 27mm biocor mitral valve.
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