- Device
- R3 DELTA Ceramic Hip System
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P150030
- Supplement
- S041
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2024-07-23
- Decision code
- OK30
- Date received
- 2024-06-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a replacement of the current micrometer with a Nanovea Optical Profilometer PS50 for measuring the overall coating thickness of vacuum plasma spray (VPS) coating of test plates (TP) coated as part of the VPS implant coating process for manufacturing POLARSTEM Stems