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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 NameTRIFECTA VALVE
Classification Nameheart-valve, non-allograft tissue
Generic Nametissue heart valve
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP100029
Supplement NumberS014
Date Received07/19/2012
Decision Date08/08/2012
Product Code
LWR[ Registered Establishments with LWR ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for adding an inspection for the maximum length for certain flaws where the depth cannot be accurately assessed.
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