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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.
 
DeviceMECHANICAL HEART VALVE, MASTERS SERIES COATED AORTIC VALVED GRAFT, MODEL CAVGJ-514 00
Classification Nameheart-valve, mechanical
Generic Nameheart-valve, mechanical
Applicant
St. Jude Medical, Inc.
one lillehei plaza
st. paul, MN 55117
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/material
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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