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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
Classification Nameheart-valve, mechanical
Generic Namemechanical heart valve
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP810002
Supplement NumberS042
Date Received04/17/1996
Decision Date05/14/1996
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling change to the st. Jude medical coated aortic valved graft (cavg), model cavg-404. The warning will instruct the physician to wet the graft with sline before cauterizing in order to prevent ignition.
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