PMA P150030S042

Device: R3 Delta Ceramic Hip System, and POLARSTEM PMA Auxiliary Products
Applicant: Smith & Nephew, Inc.
PMA number: P150030
Supplement: S042
Product code: MRA
Decision date: 2024-08-30
Classification: Orthopedic
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement: the introduction of an automated blending process for POLARSTEM stems manufacturing at Smith & Nephew Orthopaedics AG, Switzerland (SNOAG)

Current openFDA PMA Record#

Device: R3 Delta Ceramic Hip System, and POLARSTEM PMA Auxiliary Products
Applicant: Smith & Nephew, Inc.
PMA number: P150030
Supplement: S042
Product code: MRA
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date: 2024-08-30
Decision code: OK30
Date received: 2024-08-05
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the introduction of an automated blending process for POLARSTEM stems manufacturing at Smith & Nephew Orthopaedics AG, Switzerland (SNOAG)