FineTuner Echo
FDA premarket approval P000025/S108 · decided 2019-05-08
Approval details
- PMA number
- P000025
- Supplement
- S108
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FineTuner Echo
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2019-01-31
- Decision date
- 2019-05-08
- Days to decision
- 97 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- 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.
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