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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 BONE CEMENT, CMW 1, CMW 1 RADIOPAQUE, CMW 2, AND CMW 3 BONE CEMENTS.
Generic NameBONE CEMENT
Regulation Number888.3027
ApplicantDepuy, Inc.
P.O. Box 988
Warsaw, IN 46581
PMA NumberN18466
Supplement NumberS020
Date Received09/28/1995
Decision Date11/20/1995
Reclassified Date10/14/1999
Product Code LOD 
Advisory Committee Orthopedic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE FOLLOWING:1)ADDITION OF A DISTRIBUTOR LABEL TO BE PLACED ON TO THE BOTTOM OF THE OUTER CARTON; AND 2) THE STERILE POWDER PACKAGE WILL BE PLACED INTO A NONSTERILE PROTECTIVE LAMINATED FOIL POUCH
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