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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 NameMECHANICAL HEART VALVE, MASTERS SERIES COATED AORTIC VALVED GRAFT, MODEL CAVGJ-514 00
Classification Nameheart-valve, mechanical
Generic Namecoated aortic valved graft
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP810002
Supplement NumberS056
Date Received03/26/2001
Decision Date05/03/2001
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the country of origin of the bovine collagen used for the hemashield(r) graft, which is a component of the device. The device, as modified, will be marketed under the trade name st. Jude medical(r) mechanical heart valve - master series coated aortic valved graft, model cavgj-51400 in sizes 19, 21, 23, 25, 27, 29, 31, and 33 mm, and is indicated for the replacement of the aortic valve and the ascending aorta.
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