FDA.reportPublic FDA data

PMA P070026S088

Device
CERAMAX (R) Ceramic Total Hip System
Applicant
DePuy Orthopaedics, Inc.
PMA number
P070026
Supplement
S088
Product code
MRA
Decision date
2021-12-09
Generic name
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement
Approval for a change to remove suggested methods to re-sterilize products which have been opened (i.e., the sterile barrier breached) but not used during surgery in the Instructions for Use (IFU) for the CERAMAX® Ceramic Total Hip System.

Current openFDA PMA Record#

Device
CERAMAX (R) Ceramic Total Hip System
Applicant
DePuy Orthopaedics, Inc.
PMA number
P070026
Supplement
S088
Product code
MRA
Generic name
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date
2021-12-09
Decision code
APPR
Date received
2021-11-09
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for a change to remove suggested methods to re-sterilize products which have been opened (i.e., the sterile barrier breached) but not used during surgery in the Instructions for Use (IFU) for the CERAMAX® Ceramic Total Hip System.