PMA P000013S005
- Device
- OSTEONICS ABC/TRIDENT SYSTEMS
- Applicant
- Howmedica Osteonics Corp.
- PMA number
- P000013
- Supplement
- S005
- Product code
- MRA
- Decision date
- 2004-10-22
- 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 EXPANDED INDICATIONS FOR USE (INFLAMMATORY JOINT DISEASE AND REVISION HIP ARTHROPLASTY) AS WELL AS REVISIONS TO THE PACKAGE INSERT AND PATIENTS LABELING.
Current openFDA PMA Record#
- Device
- OSTEONICS ABC/TRIDENT SYSTEMS
- Applicant
- Howmedica Osteonics Corp.
- PMA number
- P000013
- Supplement
- S005
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2004-10-22
- Decision code
- APPR
- Date received
- 2004-09-09
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR EXPANDED INDICATIONS FOR USE (INFLAMMATORY JOINT DISEASE AND REVISION HIP ARTHROPLASTY) AS WELL AS REVISIONS TO THE PACKAGE INSERT AND PATIENTS LABELING.