PMA P150030S006
- Device
- R3 delta Ceramic Acetabular System
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P150030
- Supplement
- S006
- Product code
- MRA
- Decision date
- 2019-02-19
- Classification
- Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Approval order statement
- Approval for an additional supplier for the Inner Packaging Tyvek lid.
Current openFDA PMA Record#
- Device
- R3 delta Ceramic Acetabular System
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P150030
- Supplement
- S006
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2019-02-19
- Decision code
- APPR
- Date received
- 2018-11-21
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for an additional supplier for the Inner Packaging Tyvek lid.