PMA P070026S090

Device: CERAMAX Ceramic Total Hip System
Applicant: DePuy Orthopaedics, Inc.
PMA number: P070026
Supplement: S090
Product code: MRA
Decision date: 2022-02-14
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement: Movement of manufacturing steps and equipment to a 2nd building within the same establishment and address and introduction of a new clean room and additional new assets.

Current openFDA PMA Record#

Device: CERAMAX Ceramic Total Hip System
Applicant: DePuy Orthopaedics, Inc.
PMA number: P070026
Supplement: S090
Product code: MRA
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date: 2022-02-14
Decision code: OK30
Date received: 2022-02-07
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Movement of manufacturing steps and equipment to a 2nd building within the same establishment and address and introduction of a new clean room and additional new assets.