PMA N17004S009
- Device
- SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT
- Applicant
- Howmedica Corp.
- PMA number
- N17004
- Supplement
- S009
- Product code
- LOD
- Decision date
- 1997-08-08
- Classification
- Bone Cement
- Generic name
- BONE CEMENT
- Approval order statement
- APPROVAL FOR ALTERNATIVE SUPPLIER OF METHYL METHACRYLATE MONOMER.
Current openFDA PMA Record#
- Device
- SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT
- Applicant
- Howmedica Corp.
- PMA number
- N17004
- Supplement
- S009
- Product code
- LOD
- Generic name
- BONE CEMENT
- Decision date
- 1997-08-08
- Decision code
- APPR
- Date received
- 1997-06-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- APPROVAL FOR ALTERNATIVE SUPPLIER OF METHYL METHACRYLATE MONOMER.