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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 NameTRIFECA VALVE
Classification Nameheart-valve, non-allograft tissue
Generic Nametissue heart valve
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP100029
Supplement NumberS010
Date Received01/23/2012
Decision Date02/06/2012
Product Code
LWR[ Registered Establishments with LWR ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changes to include: 1) an alternate electropolishing method; 2) semi-automation of stent rotation; and 3) change in fixture material.
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