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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.
 
DeviceDEPUY 1 AND ENDURANCE BONE CEMENTS
Generic NameBONE CEMENT
Regulation Number888.3027
ApplicantDepuy, Inc.
700 Orthopaedic Dr.
Warsaw, IN 46581
PMA NumberP960001
Supplement NumberS008
Date Received05/19/1999
Decision Date09/01/1999
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
Approval Order Statement  
Approval for minor labeling changes: 1) change the package insert labeling for DePuy 1 Bone Cement from multilingual to English only; and 2) change to the package labeling for DePuy 1 and Endurance Bone Cements to remove reference to pack sizes that are approved but not currently marketed.
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