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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 NumberS045
Date Received05/05/1997
Decision Date10/21/1999
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an increase of the orifice lot sizes during the pyrolytic carbon coating process at the woodrige manufacturing facility.