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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameheart-valve, mechanical
Generic Nameheart-valve, mechanical
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.