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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.
 
DeviceST. JUDE MEDICAL MECHANICAL HEART VALVE
Generic NameHEART-VALVE, MECHANICAL
ApplicantABBOTT MEDICAL
177 County Rd. B E.
St. Paul, MN 55117
PMA NumberP810002
Supplement NumberS035
Date Received02/03/1995
Decision Date07/31/1995
Product Code LWQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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