PMA P070026S114

Device: DePuy Ceramax Ceramic Total Hip System
Applicant: DePuy Orthopaedics, Inc.
PMA number: P070026
Supplement: S114
Product code: MRA
Decision date: 2025-03-19
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-Mid-Term F/u of New COC36 Patients, for the DePuy Ceramax Ceramic Total Hip System

Current openFDA PMA Record#

Device: DePuy Ceramax Ceramic Total Hip System
Applicant: DePuy Orthopaedics, Inc.
PMA number: P070026
Supplement: S114
Product code: MRA
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date: 2025-03-19
Decision code: APPR
Date received: 2024-09-19
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-Mid-Term F/u of New COC36 Patients, for the DePuy Ceramax Ceramic Total Hip System