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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.
 
DeviceACRYLOC BONE CEMENT
Generic NameBONE CEMENT
Regulation Number888.3027
ApplicantDepuy, Inc.
P.O. Box 988
Warsaw, IN 46581
PMA NumberN18466
Supplement NumberS013
Date Received06/03/1991
Decision Date07/02/1991
Reclassified Date10/14/1999
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
Predetermined Change Control Plan AuthorizedNo
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