PMA P070026S045

Device
CERAMAX CERAMIC HIP SYSTEM
Applicant
DePuy Orthopaedics, Inc.
PMA number
P070026
Supplement
S045
Product code
MRA
Decision date
2017-02-21
Classification
Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented
Generic name
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement
Addition of a new material supplier.

Current openFDA PMA Record#

Device
CERAMAX CERAMIC HIP SYSTEM
Applicant
DePuy Orthopaedics, Inc.
PMA number
P070026
Supplement
S045
Product code
MRA
Generic name
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date
2017-02-21
Decision code
OK30
Date received
2017-01-27
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of a new material supplier.