PMA P150030S028
- Device
- R3™ DELTA CERAMIC ACETABULAR SYSTEM
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P150030
- Supplement
- S028
- Product code
- MRA
- Decision date
- 2022-11-18
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Approval order statement
- Introduction of a new cell line module into the R3 Shell production process.
Current openFDA PMA Record#
- Device
- R3™ DELTA CERAMIC ACETABULAR SYSTEM
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P150030
- Supplement
- S028
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2022-11-18
- Decision code
- OK30
- Date received
- 2022-10-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduction of a new cell line module into the R3 Shell production process.