- Device
- R3™ Delta Ceramic Acetabular System
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P150030
- Supplement
- S020
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2022-05-03
- Decision code
- OK30
- Date received
- 2022-04-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an established packaging site as a second source for performing the packaging processes of the POLARSTEM stems.