PMA P070026S057
- Device
- Ceramax Ceramic Total Hip System
- Applicant
- DePuy Orthopaedics, Inc.
- PMA number
- P070026
- Supplement
- S057
- Product code
- MRA
- Decision date
- 2019-04-24
- 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 a change to a component at a raw material supplier site, which is added to a silicone emulsion used as a denest agent.
Current openFDA PMA Record#
- Device
- Ceramax Ceramic Total Hip System
- Applicant
- DePuy Orthopaedics, Inc.
- PMA number
- P070026
- Supplement
- S057
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2019-04-24
- Decision code
- APPR
- Date received
- 2019-03-27
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a change to a component at a raw material supplier site, which is added to a silicone emulsion used as a denest agent.