PMA P000015S047
- Device
- Nucleus Auditory Brainstem Implant
- Applicant
- Cochlear Americas
- PMA number
- P000015
- Supplement
- S047
- Product code
- MHE
- Decision date
- 2022-10-31
- Generic name
- Implant, auditory brainstem
- Approval order statement
- for a new sound processor (Nucleus 8 Sound Processor) and two supporting software devices (Custom Sound Pro and Nucleus Smart App)
Current openFDA PMA Record#
- Device
- Nucleus Auditory Brainstem Implant
- Applicant
- Cochlear Americas
- PMA number
- P000015
- Supplement
- S047
- Product code
- MHE
- Generic name
- Implant, auditory brainstem
- Decision date
- 2022-10-31
- Decision code
- APPR
- Date received
- 2022-04-26
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- for a new sound processor (Nucleus 8 Sound Processor) and two supporting software devices (Custom Sound Pro and Nucleus Smart App)