R3 Delta Ceramic Hip System
FDA premarket approval P150030/S031 · decided 2023-07-28
Approval details
- PMA number
- P150030
- Supplement
- S031
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- 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
- 2023-01-30
- Decision date
- 2023-07-28
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- Approval for revisions to device labeling that was updated to include information on the Post-Approval Study (PAS), Long-Term F/u of EU patients PAS, for the R3 Delta Ceramic Hip System
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