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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 NumberS052
Date Received05/22/2000
Decision Date06/30/2000
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason postapproval study protocol - ode/oir
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to remove the condition of approval in the july 23,1998 approval order that the firm provide results from tests which demonstrate the long-term integrity of the sewing cuff attachment mechanism of the st. Jude medical(r) master series valve models.