- Device
- REFLECTION CERAMIC ACETABULAR HIP SYSTEM
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P030022
- Supplement
- S036
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2016-07-22
- Decision code
- APPR
- Date received
- 2016-06-23
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a labeling change for the REFLECTION Ceramic Acetabular Hip System which also includes the R3 Ceramic Acetabular Hip System.