FDA.reportPublic FDA data

PMA P070026S076

Device
CERAMAX Ceramic Total Hip System
Applicant
DePuy Orthopaedics, Inc.
PMA number
P070026
Supplement
S076
Product code
MRA
Decision date
2020-10-05
Generic name
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement
Updates to the chemical monitoring requirements of their porous coating vacuum furnace heat treatment for the Pinnacle Acetabular Shell and Summit Porous Femoral Stems.

Current openFDA PMA Record#

Device
CERAMAX Ceramic Total Hip System
Applicant
DePuy Orthopaedics, Inc.
PMA number
P070026
Supplement
S076
Product code
MRA
Generic name
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date
2020-10-05
Decision code
OK30
Date received
2020-09-30
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Updates to the chemical monitoring requirements of their porous coating vacuum furnace heat treatment for the Pinnacle Acetabular Shell and Summit Porous Femoral Stems.