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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.
 
DeviceOSTEOBOND(TM) COPOLYMER BONE CEMENT
Generic NameBONE CEMENT
Regulation Number888.3027
ApplicantZimmer, Inc.
P.O. Box 708
Warsaw, IN 46581
PMA NumberN17755
Supplement NumberS047
Date Received06/21/1996
Decision Date07/31/1996
Reclassified Date10/14/1999
Product Code LOD 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
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 ADDITION OF TERMINOLOGY OF "HALF BATCH, SINGLE BATCH, DOUBLE BATCH, HALF PACK, SINGLE PACK, AND DOUBLE PACK" TO THE PACKAGE LABELS FOR OSTEOBOND COPOLYMER BONE CEMENT
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