- Device
- R3 Delta Ceramic Hip System
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P150030
- Supplement
- S009
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2021-06-30
- Decision code
- OK30
- Date received
- 2021-06-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- The firms supplier (Marle SA) has integrated a glass coating as lubrication for the forging of the POLARSTEM stem forged blanks.