PMA P150030S046

Device: R3™ Delta Ceramic Acetabular System
Applicant: Smith & Nephew, Inc.
PMA number: P150030
Supplement: S046
Product code: MRA
Decision date: 2025-01-16
Classification: Orthopedic
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement: to introduce a semi-automated polishing process to the current manual polishing process for the subject R3 Acetabular Shells manufactured at Smith & Nephew Operations Sdn. Bhd, Penang, Malaysia (SNOM)

Current openFDA PMA Record#

Device: R3™ Delta Ceramic Acetabular System
Applicant: Smith & Nephew, Inc.
PMA number: P150030
Supplement: S046
Product code: MRA
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date: 2025-01-16
Decision code: OK30
Date received: 2024-12-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to introduce a semi-automated polishing process to the current manual polishing process for the subject R3 Acetabular Shells manufactured at Smith & Nephew Operations Sdn. Bhd, Penang, Malaysia (SNOM)