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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 1 AND ENDURANCE BONE CEMENTS
Classification Namebone cement
Generic Namedepuy bone cements
Regulation Number888.3027
ApplicantDEPUY, INC.
PMA NumberP960001
Supplement NumberS008
Date Received05/19/1999
Decision Date09/01/1999
Product Code
LOD[ Registered Establishments with LOD ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
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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