PMA P070026S096

Device: CERAMAX Ceramic Total Hip System
Applicant: DePuy Orthopaedics, Inc.
PMA number: P070026
Supplement: S096
Product code: MRA
Decision date: 2022-04-14
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement: Introduction of a new alternative asset (i.e., a Dry Bag Press) which will be used in the manufacturing process for the Biolox Delta Ball Head 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: S096
Product code: MRA
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date: 2022-04-14
Decision code: OK30
Date received: 2022-04-06
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Introduction of a new alternative asset (i.e., a Dry Bag Press) which will be used in the manufacturing process for the Biolox Delta Ball Head components of the CERAMAX Ceramic Total Hip System.