| 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. |
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| Trade Name | DEPUY 1 AND ENDURANCE BONE CEMENTS |
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| Classification Name | bone cement |
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| Generic Name | depuy bone cements |
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| Regulation Number | 888.3027 |
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| Applicant | DEPUY, INC. |
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| PMA Number | P960001 |
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| Supplement Number | S008 |
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| Date Received | 05/19/1999 |
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| Decision Date | 09/01/1999 |
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| Product Code | |
| Advisory Committee |
Orthopedic |
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| Supplement Type | normal 180 day track |
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| Supplement Reason | labeling change - minor |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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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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