PMA N17004S008
- Device
- SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT
- Applicant
- Howmedica Corp.
- PMA number
- N17004
- Supplement
- S008
- Product code
- LOD
- Decision date
- 1996-12-18
- Classification
- Bone Cement
- Generic name
- BONE CEMENT
- Approval order statement
- APPROVAL FOR MINOR CHANGES TO PACKAGING AND LABELING OF THE PRODUCT.
Current openFDA PMA Record#
- Device
- SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT
- Applicant
- Howmedica Corp.
- PMA number
- N17004
- Supplement
- S008
- Product code
- LOD
- Generic name
- BONE CEMENT
- Decision date
- 1996-12-18
- Decision code
- APPR
- Date received
- 1996-11-18
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR MINOR CHANGES TO PACKAGING AND LABELING OF THE PRODUCT.