PMA P040048S005

Device
TRILOGY AB ACETABULAR SYSTEM
Applicant
Zimmer, Inc.
PMA number
P040048
Supplement
S005
Product code
MRA
Decision date
2008-05-16
Generic name
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement
CHANGE IN THE GAMMA STERILIZATION DOSE VERIFICATION METHOD FOR THE TRILOGY AB ACETABULAR SYSTEM.

Current openFDA PMA Record#

Device
TRILOGY AB ACETABULAR SYSTEM
Applicant
Zimmer, Inc.
PMA number
P040048
Supplement
S005
Product code
MRA
Generic name
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date
2008-05-16
Decision code
OK30
Date received
2008-04-17
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE IN THE GAMMA STERILIZATION DOSE VERIFICATION METHOD FOR THE TRILOGY AB ACETABULAR SYSTEM.