PMA P000013S002
- Device
- OSTEONICS ABC/TRIDENT SYSTEMS
- Applicant
- Howmedica Osteonics Corp.
- PMA number
- P000013
- Supplement
- S002
- Product code
- MRA
- Decision date
- 2003-09-12
- 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 REVISIONS TO THE TRIDENT ACETABULAR SYSTEM PACKAGE INSERT AND PATIENT LABELING. THESE CHANGES INCLUDE EDITING TEXT FOR CONCISENESS AND CLARITY, REORGANIZING ELEMENTS TO MORE CLEARLY CONVEY INTENT, AND PRESENTING DATA IN A MANNER THAT IS LESS CONFUSING AND MORE MEANINGFUL TO PATIENTS AND SURGEONS.
Current openFDA PMA Record#
- Device
- OSTEONICS ABC/TRIDENT SYSTEMS
- Applicant
- Howmedica Osteonics Corp.
- PMA number
- P000013
- Supplement
- S002
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2003-09-12
- Decision code
- APPR
- Date received
- 2003-06-12
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR REVISIONS TO THE TRIDENT ACETABULAR SYSTEM PACKAGE INSERT AND PATIENT LABELING. THESE CHANGES INCLUDE EDITING TEXT FOR CONCISENESS AND CLARITY, REORGANIZING ELEMENTS TO MORE CLEARLY CONVEY INTENT, AND PRESENTING DATA IN A MANNER THAT IS LESS CONFUSING AND MORE MEANINGFUL TO PATIENTS AND SURGEONS.