- Device
- R3 Delta Ceramic Acetabular System
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P150030
- Supplement
- S026
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2022-09-21
- Decision code
- OK30
- Date received
- 2022-08-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an additional hydraulic press for the forging process of the SYNERGY stems at the supplier site.