|
Device | DEPUY 1 AND ENDURANCE BONE CEMENTS |
Generic Name | BONE CEMENT |
Regulation Number | 888.3027 |
Applicant | DEPUY, INC. 700 ORTHOPAEDIC DR. WARSAW, IN 46581-0988 |
PMA Number | P960001 |
Supplement Number | S008 |
Date Received | 05/19/1999 |
Decision Date | 09/01/1999 |
Reclassified Date
|
10/14/1999 |
Product Code |
LOD |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
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. |