PMA P070026S113
- Device
- CERAMAX Ceramic Total Hip System
- Applicant
- DePuy Orthopaedics, Inc.
- PMA number
- P070026
- Supplement
- S113
- Product code
- MRA
- Decision date
- 2024-10-23
- Classification
- Orthopedic
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Approval order statement
- approval for MRI Compatibility labeling updates and other minor labeling updates
Current openFDA PMA Record#
- Device
- CERAMAX Ceramic Total Hip System
- Applicant
- DePuy Orthopaedics, Inc.
- PMA number
- P070026
- Supplement
- S113
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2024-10-23
- Decision code
- APPR
- Date received
- 2024-07-25
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- approval for MRI Compatibility labeling updates and other minor labeling updates