PMA P150030S001
- Device
- R3 DELTA CERAMIC HIP SYSTEM
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P150030
- Supplement
- S001
- Product code
- MRA
- Decision date
- 2016-12-21
- 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 a manufacturing site located at Synergy Health Sterilisation UK Ltd., Drayton Fields Industrial Estate, Brunel Close, Daventry Northamptonshire, UK NN11 8RB for sterilization of the R3 delta Hip System.
Current openFDA PMA Record#
- Device
- R3 DELTA CERAMIC HIP SYSTEM
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P150030
- Supplement
- S001
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2016-12-21
- Decision code
- APPR
- Date received
- 2016-11-07
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at Synergy Health Sterilisation UK Ltd., Drayton Fields Industrial Estate, Brunel Close, Daventry Northamptonshire, UK NN11 8RB for sterilization of the R3 delta Hip System.