PMA P070026S115

Device: CERAMAX Ceramic Hip System
Applicant: DePuy Orthopaedics, Inc.
PMA number: P070026
Supplement: S115
Product code: MRA
Decision date: 2024-11-08
Classification: Orthopedic
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement: the elimination of the first-off label roll stock verification step for both CE and Non-CE product variants and replacing it with 100 percent barcode scanning of the UDI barcode on Implant Card of the MDR CE patient label

Current openFDA PMA Record#

Device: CERAMAX Ceramic Hip System
Applicant: DePuy Orthopaedics, Inc.
PMA number: P070026
Supplement: S115
Product code: MRA
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date: 2024-11-08
Decision code: OK30
Date received: 2024-10-29
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the elimination of the first-off label roll stock verification step for both CE and Non-CE product variants and replacing it with 100 percent barcode scanning of the UDI barcode on Implant Card of the MDR CE patient label