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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.
 
DeviceREGENT, STANDARD AND MASTERS MECHANICAL HEART VALVE
Classification Nameheart-valve, mechanical
Generic Nameheart-valve, mechanical
Applicant
St. Jude Medical, Inc.
one lillehei plaza
st. paul, MN 55117
PMA NumberP810002
Supplement NumberS088
Date Received12/03/2013
Decision Date12/19/2013
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 
IMPLEMENTATION OF A NEW SEALING PLATE CONFIGURATION AND A CHANGE IN SEALING PARAMETERS FOR THE TYVEK LID OF THE INNER AND OUTER TRAYS FOR MECHANICAL HEART VALVE PACKAGING AT ONE MANUFACTURING FACILITY.
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