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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.
 
DeviceSJM Master Series Mechanical Heart Valve with Silzone Coating, Expanded Polyester Cuff with Silzone Coating, HP Cuff wit
Generic NameHEART-VALVE, MECHANICAL
ApplicantAbbott Medical
177 County Road B. East
St. Paul, MN 55117
PMA NumberP810002
Supplement NumberS098
Date Received09/29/2016
Decision Date12/01/2016
Product Code LWQ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for revisions to the MRI safety labeling.
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