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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 MECHANICAL HEART VALVE SJM MASTERS SERIES WITH SILZONE
Classification Nameheart-valve, mechanical
Generic Namemechanical heart valve
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP810002
Supplement NumberS047
Date Received06/26/1998
Decision Date07/14/1998
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The 30 day requested approval for a ptfe fabric supplier change.
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