PMA P200021S002
- Device
- Neuro Cochlear Implant System
- Applicant
- Oticon Medical
- Product code
- MCM
- Decision date
- 2021-11-08
- Generic name
- Implant, cochlear
- Approval order statement
- Approval for changes to the external Neuro 2 Sound Processor firmware and to the Genie Medical Cochlear Implant fitting software.
Current openFDA PMA Record#
- Device
- Neuro Cochlear Implant System
- Applicant
- Oticon Medical
- PMA number
- P200021
- Supplement
- S002
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2021-11-08
- Decision code
- APPR
- Date received
- 2021-08-06
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for changes to the external Neuro 2 Sound Processor firmware and to the Genie Medical Cochlear Implant fitting software.