R3 Delta Ceramic Hip System
FDA premarket approval P150030/S045 · decided 2025-02-28
Approval details
- PMA number
- P150030
- Supplement
- S045
- 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
- 2024-09-03
- Decision date
- 2025-02-28
- Days to decision
- 178 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), Short to Mid-term f/u of New US patients PAS, for the R3 Delta Ceramic Hip System.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.