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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 SJM MASTERS SERIES WITH SILZONE
Classification Nameheart-valve, mechanical
Generic Nameheart-valve, mechanical
Applicant
St. Jude Medical, Inc.
one lillehei plaza
st. paul, MN 55117
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 - manufacturer/sterilizer/packager/supplier
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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