PMA P070026S040

Device
CERAMAX Ceramic Total Hip System
Applicant
DePuy Orthopaedics, Inc.
PMA number
P070026
Supplement
S040
Product code
MRA
Decision date
2017-08-18
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
Approval of the manufacturing site.

Current openFDA PMA Record#

Device
CERAMAX Ceramic Total Hip System
Applicant
DePuy Orthopaedics, Inc.
PMA number
P070026
Supplement
S040
Product code
MRA
Generic name
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date
2017-08-18
Decision code
APPR
Date received
2016-07-29
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval of the manufacturing site.