R3 DELTA CERAMIC HIP SYSTEM
FDA premarket approval P150030/S001 · decided 2016-12-21
Approval details
- PMA number
- P150030
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- R3 DELTA CERAMIC HIP SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2016-11-07
- Decision date
- 2016-12-21
- Days to decision
- 44 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., Drayton Fields Industrial Estate, Brunel Close, Daventry Northamptonshire, UK NN11 8RB for sterilization of the R3 delta Hip System.
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