PMA P030022S043
- Device
- REFLECTION Ceramic Acetabular Hip System (RCHS)
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P030022
- Supplement
- S043
- Product code
- MRA
- Decision date
- 2017-06-02
- 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
- Separation of the water treatment system and replacement of some water treatment machinery.
Current openFDA PMA Record#
- Device
- REFLECTION Ceramic Acetabular Hip System (RCHS)
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P030022
- Supplement
- S043
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2017-06-02
- Decision code
- OK30
- Date received
- 2017-05-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Separation of the water treatment system and replacement of some water treatment machinery.