- Device
- RCHS Ceramic Liners and Shells
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P030022
- Supplement
- S044
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2017-08-17
- Decision code
- OK30
- Date received
- 2017-07-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the outer packaging carton for P030022, so that it is consistent with the approved packaging.