PMA P150030S048

Device: R3 DELTA CERAMIC HIP SYSTEM
Applicant: Smith & Nephew, Inc.
PMA number: P150030
Supplement: S048
Product code: MRA
Decision date: 2025-03-03
Classification: Orthopedic
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement: a software update for the laser marking machine for POLARSTEM (PMA Auxiliary Products) manufactured at Smith & Nephew Orthopaedics AG, Switzerland (SNOAG).

Current openFDA PMA Record#

Device: R3 DELTA CERAMIC HIP SYSTEM
Applicant: Smith & Nephew, Inc.
PMA number: P150030
Supplement: S048
Product code: MRA
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date: 2025-03-03
Decision code: OK30
Date received: 2025-02-04
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a software update for the laser marking machine for POLARSTEM (PMA Auxiliary Products) manufactured at Smith & Nephew Orthopaedics AG, Switzerland (SNOAG).