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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.
 
DeviceTHE ST. JUDE MEDICAL(R) MECHANICAL HEART VALVE SJM(R) MASTERS SERIES
Classification Nameheart-valve, mechanical
Generic Nameheart-valve, mechanical
Applicant
St. Jude Medical, Inc.
one lillehei plaza
st. paul, MN 55117
PMA NumberP810002
Supplement NumberS036
Date Received05/05/1995
Decision Date11/28/1995
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A ROTATABLE VERSION OF THE ST.JUDE MEDICAL MECHANICAL HEART VALVE - THE DEVICE AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME:ST. JUDE MEDICAL MASTER SERIES AND WILL BE AVAILABLE IN THE FOLLOWING MODEL NUMBERS AND SIZES:AJ-501 AND AECJ-502 (19, 21, 23, 25, 27, 29, AND 31 MM), MJ-501 AND MECJ-502 (19, 21, 23, 25, 27, 29, 31, AND 33MM) AND AHPJ-505, MHPJ-505, AEJPJ-506, AND MEHPJ-506 (17, 19, 21, 23, 25, AND 27MM). THE SUPPLEMENT ALSO INCLUDES A VALVE HOLDER/ROTATOR ACCESSORY WHICH WILL BE INCLUDED AS A COMPONENT OF THE MECHANICAL HEART VALVE SIZER SET MODEL 905
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