PMA P960001S008

Device: DEPUY 1 AND ENDURANCE BONE CEMENTS
Applicant: Depuy, Inc.
PMA number: P960001
Supplement: S008
Product code: LOD
Decision date: 1999-09-01
Generic name: BONE CEMENT
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.

Current openFDA PMA Record

Device: DEPUY 1 AND ENDURANCE BONE CEMENTS
Applicant: Depuy, Inc.
PMA number: P960001
Supplement: S008
Product code: LOD
Generic name: BONE CEMENT
Decision date: 1999-09-01
Decision code: APPR
Date received: 1999-05-19
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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.