|Trade Name||DEPUY 1 AND ENDURANCE BONE CEMENTS|
|Classification Name||bone cement|
|Generic Name||bone cement|
|Supplement Type||normal 180 day track|
|Supplement Reason|| labeling change - indications/instructions/shelf life/tradename|
|Expedited Review Granted?|| 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.