REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS)
FDA premarket approval P030022/S038 · decided 2016-12-21
Approval details
- PMA number
- P030022
- Supplement
- S038
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS)
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2016-07-15
- Decision date
- 2016-12-21
- Days to decision
- 159 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- Approval for a manufacturing site located at Synergy Health Sterilisation UK Ltd., Brunel Close, Drayton Fields Industrial Estate, Daventry, Northamptonshire, UK NN11 8RB for the sterilization of the R3 acetabular shells which are part of the Reflection Ceramic Acetabular Hip System.
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