FDA.reportPublic FDA data

PMA P000025S108

Device
FineTuner Echo
Applicant
Med-El Corp.
PMA number
P000025
Supplement
S108
Product code
MCM
Decision date
2019-05-08
Classification
Implant, Cochlear
Generic name
Implant, cochlear
Approval order statement
Approval for the FineTuner Echo of the Med-El Cochlear Implant System, which is a remote control (optional accessory) for compatible audio processors. It is the hardware successor of the previously approved FineTuner and includes minor design changes to the graphical user interface.

Current openFDA PMA Record#

Device
FineTuner Echo
Applicant
Med-El Corp.
PMA number
P000025
Supplement
S108
Product code
MCM
Generic name
Implant, cochlear
Decision date
2019-05-08
Decision code
APPR
Date received
2019-01-31
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for the FineTuner Echo of the Med-El Cochlear Implant System, which is a remote control (optional accessory) for compatible audio processors. It is the hardware successor of the previously approved FineTuner and includes minor design changes to the graphical user interface.