PMA P150030S007
- Device
- R3 delta Ceramic Acetabular System
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P150030
- Supplement
- S007
- Product code
- MRA
- Decision date
- 2019-06-07
- 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
- Cooling lubricant change for the R3™ delta Ceramic Acetabular System.
Current openFDA PMA Record#
- Device
- R3 delta Ceramic Acetabular System
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P150030
- Supplement
- S007
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2019-06-07
- Decision code
- OK30
- Date received
- 2019-05-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Cooling lubricant change for the R3™ delta Ceramic Acetabular System.