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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 MASTERS SERIES MECHANICAL HEART VALVE
Generic NameHEART-VALVE, MECHANICAL
ApplicantAbbott Medical
177 County Road B. East
St. Paul, MN 55117
PMA NumberP810002
Supplement NumberS048
Date Received11/04/1998
Decision Date04/16/1999
Product Code LWQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the addition of 35mm and 37mm mitral valve sizes to the SJM(R) Master Series Mechanical Heart Valve product line (SJM(TM) Master Series with Polyester Cuff, model number MJ-501, and SJM(R) Master Series with Silzone(TM) coating, Polyester Cuff, model number MS-601).
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