R3 DELTA CERAMIC HIP SYSTEM
FDA premarket approval P150030/S017 · decided 2021-12-08
Approval details
- PMA number
- P150030
- Supplement
- S017
- 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
- 2021-11-08
- Decision date
- 2021-12-08
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- Approval for a manufacturing site located at Synergey Health Daniken AG (a.k.a STERIS), Daniken So, Solothurn, 4658 Switzerland as an alternative vendor for gamma sterilization of the R3TM US Delta Ceramic Liner and R3TM US Delta Ceramic Heads.
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