- Device
- Nucleus 24 Auditory Brainstem Implant System
- Applicant
- Cochlear Americas
- PMA number
- P000015
- Supplement
- S049
- Product code
- MHE
- Generic name
- Implant, auditory brainstem
- Decision date
- 2023-04-24
- Decision code
- APPR
- Date received
- 2023-01-20
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for changes to the material and design of the coil crimp and its joining process used in the CI500 Series & CI600 Series Cochlear Implants and the ABI541 Auditory Brainstem Implant