PMA P070026S052
- Device
- Ceramax Ceramic Total Hip System
- Applicant
- DePuy Orthopaedics, Inc.
- PMA number
- P070026
- Supplement
- S052
- Product code
- MRA
- Decision date
- 2018-03-26
- 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
- Inclusion of an additional alternate method of automated manufacturing at the porous coating process step.
Current openFDA PMA Record#
- Device
- Ceramax Ceramic Total Hip System
- Applicant
- DePuy Orthopaedics, Inc.
- PMA number
- P070026
- Supplement
- S052
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2018-03-26
- Decision code
- OK30
- Date received
- 2018-02-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Inclusion of an additional alternate method of automated manufacturing at the porous coating process step.