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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 SJM(R) MASTER SERIES
Generic NameHEART-VALVE, MECHANICAL
ApplicantAbbott Medical
177 County Road B. East
St. Paul, MN 55117
PMA NumberP810002
Supplement NumberS038
Date Received08/15/1995
Decision Date03/13/1996
Product Code LWQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR AN EXTENSION OF THE SHELF LIFE OF THE ST. JUDE MEDICAL MECHANICAL HEART VALVE (ALL CURRENTLY APPROVED MODELS) AND THE COATED AORTIC VALVED GRAFT (CAVG), MODEL CAVG-404
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