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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.
 
DeviceORTHOSET BONE CEMENT
Generic NameBONE CEMENT
Regulation Number888.3027
ApplicantDEPUY, INC.
P.O. BOX 988
WARSAW, IN 46581-0988
PMA NumberN18466
Supplement NumberS023
Date Received10/01/1998
Decision Date10/21/1998
Reclassified Date 10/14/1999
Product Code LOD 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval to remove the ascorbic acid and ethanol components from the liquid monomer formulation in your Orthoset 1, Orthoset 2, and Orthoset 3 bone cements, as well as approval to omit the quality control test for dimensional change from the finished product specification.
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