FDA.reportPublic FDA data

PMA P070026S078

Device
CERAMAX Ceramic Total Hip System
Applicant
DePuy Orthopaedics, Inc.
PMA number
P070026
Supplement
S078
Product code
MRA
Decision date
2020-11-30
Generic name
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement
Change is a modification of an existing mask at the Porocoat process step and the introduction of a new mask to eliminate rework at the Polish process step for hip components for the CERAMAX® Ceramic Total Hip System.

Current openFDA PMA Record#

Device
CERAMAX Ceramic Total Hip System
Applicant
DePuy Orthopaedics, Inc.
PMA number
P070026
Supplement
S078
Product code
MRA
Generic name
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date
2020-11-30
Decision code
OK30
Date received
2020-11-25
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change is a modification of an existing mask at the Porocoat process step and the introduction of a new mask to eliminate rework at the Polish process step for hip components for the CERAMAX® Ceramic Total Hip System.