R3 DELTA CERAMIC HIP SYSTEM
FDA premarket approval P150030/S032 · decided 2023-03-30
Approval details
- PMA number
- P150030
- Supplement
- S032
- Supplement type
- 30-Day Notice
- Supplement reason
- Process 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
- 2023-03-02
- Decision date
- 2023-03-30
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- Implementation of a new manufacturing cell (AC1) for the manufacturing of R3 Acetabular shells at Smith & Nephew Aurora, Leamington Spa, UK facility.
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