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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameST JUDE MEDICAL TRIFECTA VALVE
Classification Nameheart-valve, non-allograft tissue
Generic Nametissue heart valve
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP100029
Date Received07/20/2010
Decision Date04/20/2011
Product Code
LWR[ Registered Establishments with LWR ]
Docket Number 11M-0296
Notice Date 05/06/2011
Advisory Committee Cardiovascular
Clinical Trials NCT00475709
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the st. Jude medical trifecta valve. The trifecta valve is intended as a replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic heart valve.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 
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