PMA N17004S010
- Device
- SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT
- Applicant
- Howmedica Corp.
- PMA number
- N17004
- Supplement
- S010
- Product code
- LOD
- Decision date
- 1997-11-13
- Classification
- Bone Cement
- Generic name
- BONE CEMENT
- Approval order statement
- Approval for the elimination of a series of duplicative tests that are performed on the Surgical Simplex(R) P Bone Cement.
Current openFDA PMA Record#
- Device
- SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT
- Applicant
- Howmedica Corp.
- PMA number
- N17004
- Supplement
- S010
- Product code
- LOD
- Generic name
- BONE CEMENT
- Decision date
- 1997-11-13
- Decision code
- APPR
- Date received
- 1997-10-17
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the elimination of a series of duplicative tests that are performed on the Surgical Simplex(R) P Bone Cement.