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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 NameDEPUY 3 BONE CEMENT
Classification Namebone cement
Generic Namedepuy bone cements
Regulation Number888.3027
ApplicantDEPUY, INC.
PMA NumberP960001
Supplement NumberS007
Date Received07/30/1998
Decision Date08/27/1998
Product Code
LOD[ Registered Establishments with LOD ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the inclusion of endurance bone cement within a pre-packaged "kit" for cemented hip or knee replacement procedures.
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