Neuro Cochlear Implant System
FDA premarket approval P200021/S002 · decided 2021-11-08
Approval details
- PMA number
- P200021
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Neuro Cochlear Implant System
- Generic name
- Implant, cochlear
- Applicant
- Oticon Medical
- Date received
- 2021-08-06
- Decision date
- 2021-11-08
- Days to decision
- 94 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- 06220 Vallauris
- Statement
- Approval for changes to the external Neuro 2 Sound Processor firmware and to the Genie Medical Cochlear Implant fitting software.
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