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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 PROSTHESIS WITH VASCUTEK GELWEAVE VALSALVA GRAFT (MODEL VAVGJ-515)
Classification Nameheart-valve, mechanical
Generic Namecoated aortic valved graft
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP810002
Supplement NumberS058
Date Received01/03/2005
Decision Date02/14/2005
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an additional configuration of the aortic valved graft using the sjm masters series aortic valved prosthesis with the vascutek gelweave valsalva graft. The device, as modified, will be marketed under the trade name sjm masters series aortic valved prosthesis with vascutek gelweave valsalva graft (model vavgj-515) and is indicated for the replacement of a malfunctioning native or prosthetic aortic heart valve and ascending aorta.
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