PMA P150030S045

Device: R3 Delta Ceramic Hip System
Applicant: Smith & Nephew, Inc.
PMA number: P150030
Supplement: S045
Product code: MRA
Decision date: 2025-02-28
Classification: Orthopedic
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order 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.

Current openFDA PMA Record#

Device: R3 Delta Ceramic Hip System
Applicant: Smith & Nephew, Inc.
PMA number: P150030
Supplement: S045
Product code: MRA
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date: 2025-02-28
Decision code: APPR
Date received: 2024-09-03
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order 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.