PMA P070026S075

Device
CERAMAX Ceramic Total Hip System
Applicant
DePuy Orthopaedics, Inc.
PMA number
P070026
Supplement
S075
Product code
MRA
Decision date
2020-07-15
Generic name
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement
Supplier relocation of manufacturing facility.

Current openFDA PMA Record#

Device
CERAMAX Ceramic Total Hip System
Applicant
DePuy Orthopaedics, Inc.
PMA number
P070026
Supplement
S075
Product code
MRA
Generic name
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date
2020-07-15
Decision code
OK30
Date received
2020-06-23
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Supplier relocation of manufacturing facility.