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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.
Classification Nameheart-valve, mechanical
Generic Nameheart-valve, mechanical
St. Jude Medical, Inc.
one lillehei plaza
st. paul, MN 55117
PMA NumberP810002
Supplement NumberS078
Date Received08/17/2011
Decision Date11/01/2012
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to update the instructions for use (ifu), st. Jude medical (sjm) internet, and any other applicable device labeling to include the new magnetic resonance imaging (mri) testing information to enhance the safe use of the device when undergoing mri.