R3 Delta Ceramic Acetabular System
FDA premarket approval P150030/S049 · decided 2025-04-17
Approval details
- PMA number
- P150030
- Supplement
- S049
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- R3 Delta Ceramic Acetabular System
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2025-03-21
- Decision date
- 2025-04-17
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- a change to the final cleaning monitoring process to reduce the frequency of product endotoxin testing from bi-weekly to quarterly for the R3 Shells at Smith & Nephew Operations Malaysia (SNOM)
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