PMA P070026S102

Device: CERAMAX® Ceramic Total Hip System
Applicant: DePuy Orthopaedics, Inc.
PMA number: P070026
Supplement: S102
Product code: MRA
Decision date: 2022-10-04
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement: Process change by introducing new sealing parameters and the use of six (6) cavities as opposed to the current four (4) cavities that are used to package some components of the CERAMAX Ceramic Total Hip system.

Current openFDA PMA Record#

Device: CERAMAX® Ceramic Total Hip System
Applicant: DePuy Orthopaedics, Inc.
PMA number: P070026
Supplement: S102
Product code: MRA
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date: 2022-10-04
Decision code: OK30
Date received: 2022-09-07
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Process change by introducing new sealing parameters and the use of six (6) cavities as opposed to the current four (4) cavities that are used to package some components of the CERAMAX Ceramic Total Hip system.