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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 NameSJM MASTERS SERIES AORTIC VALVED GRAFT (MODEL CAVGJ), AND THE SJM MASTERS HP VALVED GRAFT (MODEL VAVGJ)
Classification Nameheart-valve, mechanical
Generic Namecoated aortic valved graft
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP810002
Supplement NumberS067
Date Received07/03/2008
Decision Date08/29/2008
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modification to the packaging for the referenced models.
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