PMA N17004S011
- Device
- SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT
- Applicant
- Howmedica Corp.
- PMA number
- N17004
- Supplement
- S011
- Product code
- LOD
- Decision date
- 1998-03-18
- Classification
- Bone Cement
- Generic name
- BONE CEMENT
- Approval order statement
- Approval for Isotron Ireland, LTD., to be certified as an alternate supplier for your ETO sterilization process.
Current openFDA PMA Record#
- Device
- SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT
- Applicant
- Howmedica Corp.
- PMA number
- N17004
- Supplement
- S011
- Product code
- LOD
- Generic name
- BONE CEMENT
- Decision date
- 1998-03-18
- Decision code
- APPR
- Date received
- 1998-02-03
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for Isotron Ireland, LTD., to be certified as an alternate supplier for your ETO sterilization process.