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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.
 
DeviceCMW ORTHOPEDIC BONE CEMENT
Generic NameBONE CEMENT
Regulation Number888.3027
ApplicantDEPUY, INC.
P.O. BOX 988
WARSAW, IN 46581-0988
PMA NumberN18466
Supplement NumberS016
Date Received11/08/1994
Decision Date06/21/1995
Reclassified Date 10/14/1999
Product Code LOD 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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