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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 Namecoated aortic valved graft
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP810002
Supplement NumberS077
Date Received07/05/2011
Decision Date11/10/2011
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for eliminating the use of one method for coating thickness image capture and replace it with a new method.
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