PMA P960001S003

Device: ENDURANCE BONE CEMENT
Applicant: Depuy, Inc.
PMA number: P960001
Supplement: S003
Product code: LOD
Decision date: 1998-01-27
Generic name: BONE CEMENT
Approval order statement: Approval for the following changes: 1) to remove ascorbic acid and ethanol from the liquid monomer formulation; and 2) omit the quality control test for dimensional change from the finished product specification.

Current openFDA PMA Record

Device: ENDURANCE BONE CEMENT
Applicant: Depuy, Inc.
PMA number: P960001
Supplement: S003
Product code: LOD
Generic name: BONE CEMENT
Decision date: 1998-01-27
Decision code: APPR
Date received: 1997-11-17
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the following changes: 1) to remove ascorbic acid and ethanol from the liquid monomer formulation; and 2) omit the quality control test for dimensional change from the finished product specification.