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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameOSTEOBOND(TM) COPOLYMER BONE CEMENT
Classification Namebone cement
Generic Namebone cement
Regulation Number888.3027
ApplicantZIMMER, INC.
PMA NumberN17755
Supplement NumberS047
Date Received06/21/1996
Decision Date07/31/1996
Product Code
LOD[ Registered Establishments with LOD ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
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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