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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.
 
DeviceMECHANICAL HEART VALVE SJM(R) MASTER SERIES
Classification Nameheart-valve, mechanical
Generic Nameheart-valve, mechanical
Applicant
St. Jude Medical, Inc.
one lillehei plaza
st. paul, MN 55117
PMA NumberP810002
Supplement NumberS038
Date Received08/15/1995
Decision Date03/13/1996
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an extension of the shelf life of the st. Jude medical mechanical heart valve (all currently approved models) and the coated aortic valved graft (cavg), model cavg-404.
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