PMA P000013S011
- Device
- TRIDENT CERAMIC-ON-CERAMIC ACETABULAR SYSTEM
- Applicant
- Howmedica Osteonics Corp.
- PMA number
- P000013
- Supplement
- S011
- Product code
- MRA
- Decision date
- 2012-11-02
- Classification
- Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Approval order statement
- APPROVAL FOR LABELING UPDATES INCORPORATING RESULTS OF THE COMPLETED POST-APPROVAL STUDY.
Current openFDA PMA Record#
- Device
- TRIDENT CERAMIC-ON-CERAMIC ACETABULAR SYSTEM
- Applicant
- Howmedica Osteonics Corp.
- PMA number
- P000013
- Supplement
- S011
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2012-11-02
- Decision code
- APPR
- Date received
- 2011-11-10
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- APPROVAL FOR LABELING UPDATES INCORPORATING RESULTS OF THE COMPLETED POST-APPROVAL STUDY.