PMA P000013S003
- Device
- OSTEONICS ABC SYSTEM AND TRIDENT SYSTEM
- Applicant
- Howmedica Osteonics Corp.
- PMA number
- P000013
- Supplement
- S003
- Product code
- MRA
- Decision date
- 2003-11-13
- 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 OF THE POST-APPROVAL STUDY PROTOCOL FOR THE DEVICE.
Current openFDA PMA Record#
- Device
- OSTEONICS ABC SYSTEM AND TRIDENT SYSTEM
- Applicant
- Howmedica Osteonics Corp.
- PMA number
- P000013
- Supplement
- S003
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2003-11-13
- Decision code
- APPR
- Date received
- 2003-08-13
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL FOR THE DEVICE.