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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceST. JUDE MEDICAL MECHANICAL HEART VALVE
Generic NameHEART-VALVE, MECHANICAL
ApplicantAbbott Medical
177 County Road B. East
St. Paul, MN 55117
PMA NumberP810002
Supplement NumberS078
Date Received08/17/2011
Decision Date11/01/2012
Product Code LWQ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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.
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