PMA N18466
- Device
- Orthoset Bone Cement
- Applicant
- DEPUY, INC.
- PMA number
- N18466
- Supplement
- S023
- Decision date
- 1998-10-21
Current openFDA PMA Record
- Device
- ORTHOSET BONE CEMENT
- Applicant
- Depuy, Inc.
- PMA number
- N18466
- Supplement
- S023
- Product code
- LOD
- Generic name
- BONE CEMENT
- Decision date
- 1998-10-21
- Decision code
- APPR
- Date received
- 1998-10-01
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to remove the ascorbic acid and ethanol components from the liquid monomer formulation in your Orthoset 1, Orthoset 2, and Orthoset 3 bone cements, as well as approval to omit the quality control test for dimensional change from the finished product specification.