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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 (EXPANDED SEWING CUFF)
Generic NameHEART-VALVE, MECHANICAL
ApplicantAbbott Medical
177 County Road B. East
St. Paul, MN 55117
PMA NumberP810002
Supplement NumberS039
Date Received09/11/1995
Decision Date03/21/1996
Product Code LWQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR AN EXPANDED VERSION OF THE ST. JUDE MEDICAL MECHANICAL HEART VALVE WITH TEFLON SEWING CUFF. THE NEW MODELS WILL BE AVAILABLE IN THE AORTIC SIZES OF 19, 21, 23, 25, 27, 29, AND 31 MM (AET-104) AND THE MITRAL SIZES OF 19, 21, 23, 25, 27, 29, 31, AND 33MM (MET-104)
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