PMA P070026S087
- Device
- CERAMAX Ceramic Total Hip System
- Applicant
- DePuy Orthopaedics, Inc.
- PMA number
- P070026
- Supplement
- S087
- Product code
- MRA
- Decision date
- 2021-11-05
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Approval order statement
- Process change that increases SR-T tolerance limits for the HIP-sintering step.
Current openFDA PMA Record#
- Device
- CERAMAX Ceramic Total Hip System
- Applicant
- DePuy Orthopaedics, Inc.
- PMA number
- P070026
- Supplement
- S087
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2021-11-05
- Decision code
- OK30
- Date received
- 2021-11-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Process change that increases SR-T tolerance limits for the HIP-sintering step.