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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.
 
DeviceENDURANCE BONE CEMENT
Generic NameBONE CEMENT
Regulation Number888.3027
ApplicantDEPUY, INC.
700 ORTHOPAEDIC DR.
WARSAW, IN 46581-0988
PMA NumberP960001
Supplement NumberS003
Date Received11/17/1997
Decision Date01/27/1998
Reclassified Date 10/14/1999
Product Code LOD 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the following changes: 1) to remove ascorbic acid and ethanol from the liquid monomer formulation; and 2) omit the quality control test for dimensional change from the finished product specification.
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