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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSJM MASTERS SERIES AORTIC VALVED PROSTHESIS WITH VASCUTEK GELWEAVE VALSALVA GRAFT (MODEL VAVGJ-515)
Generic NameHEART-VALVE, MECHANICAL
ApplicantAbbott Medical
177 County Road B. East
St. Paul, MN 55117
PMA NumberP810002
Supplement NumberS058
Date Received01/03/2005
Decision Date02/14/2005
Product Code LWQ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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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