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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.
 
DeviceST. JUDE MEDICAL REGENT MECHANICAL HEART VALVE (AORTIC)
Generic NameHEART-VALVE, MECHANICAL
ApplicantAbbott Medical
177 County Road B. East
St. Paul, MN 55117
PMA NumberP810002
Supplement NumberS057
Date Received09/07/2001
Decision Date03/04/2002
Product Code LWQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A MODIFIED VERSION OF THE SJM STANDARD VALVE, SIZES 19, 21, 23, 25 AND 27 MM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME REGENT MECHANICAL HEART VALVE AND IS INDICATED AS A REPLACEMENT VALVE IN PATIENTS WITH A DISEASED, DAMAGED, OR MALFUNCTIONING AORTIC VALVE. THIS DEVICE MAY ALSO BE USED TO REPLACE A PREVIOUSLY IMPLANTED PROSTHETIC HEART VALVE.
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