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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 NameST. JUDE MEDICAL MASTERS SERIES MECHANICAL HEART VALVE
Classification Nameheart-valve, mechanical
Generic Namemechanical heart valve
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP810002
Supplement NumberS048
Date Received11/04/1998
Decision Date04/16/1999
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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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