PMA P070026S077
- Device
- CERAMAX Ceramic Total Hip System
- Applicant
- DePuy Orthopaedics, Inc.
- PMA number
- P070026
- Supplement
- S077
- Product code
- MRA
- Decision date
- 2020-11-19
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Approval order statement
- Relocation of the manufacturing process for the S-ROM® Stem components.
Current openFDA PMA Record#
- Device
- CERAMAX Ceramic Total Hip System
- Applicant
- DePuy Orthopaedics, Inc.
- PMA number
- P070026
- Supplement
- S077
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2020-11-19
- Decision code
- OK30
- Date received
- 2020-11-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Relocation of the manufacturing process for the S-ROM® Stem components.