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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.
 
Trade NameST. JUDE MEDICAL MECHANICAL HEART VALVE
Classification Nameheart-valve, mechanical
Generic Namemechanical heart valve
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP810002
Supplement NumberS035
Date Received02/03/1995
Decision Date07/31/1995
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for use of the woodridge carbon technology center, little canada, minnesota, as an alternate supplier of the pyrolitic carbon leaflet & orifice components used in the st. Jude medical mechanical heart valve.
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