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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 NameMASTERS SERIES COATED AORTIC VALVED GRAFT(MODEL CAVGJ-514)
Classification Nameheart-valve, mechanical
Generic Namemechanical heart valve
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP810002
Supplement NumberS049
Date Received02/09/1999
Decision Date07/28/1999
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the sjm(r) master series aortic valved graft with meadox(r) hemashield(r) woven double velour graft, model cavgj-514, in sizes 19, 21, 23, 25, 27, 29, 31, and 33 mm. This device is indicated for use when the aortic valve and the ascending aorta must be replaced.
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