- Device
- R3 DELTA CERAMIC ACETABULAR SYSTEM
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P150030
- Supplement
- S040
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2024-06-27
- Decision code
- OK30
- Date received
- 2024-05-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to introduce a new production aid for the wastewater treatment in the drag finishing process for POLARSTEM.