PMA P960058S107

Device
HIRESOLUTION BIONIC EAR SYSTEM
Applicant
Advanced Bionics
PMA number
P960058
Supplement
S107
Product code
MCM
Decision date
2014-02-14
Classification
Implant, Cochlear
Generic name
Implant, cochlear
Approval order statement
AUTOMATION OF AN IN-PROCESS CONTINUITY TEST.

Current openFDA PMA Record#

Device
HIRESOLUTION BIONIC EAR SYSTEM
Applicant
Advanced Bionics
PMA number
P960058
Supplement
S107
Product code
MCM
Generic name
Implant, cochlear
Decision date
2014-02-14
Decision code
OK30
Date received
2014-01-16
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
AUTOMATION OF AN IN-PROCESS CONTINUITY TEST.