Nucleus 24 Auditory Brainstem Implant System
FDA premarket approval P000015/S049 · decided 2023-04-24
Approval details
- PMA number
- P000015
- Supplement
- S049
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Nucleus 24 Auditory Brainstem Implant System
- Generic name
- Implant, auditory brainstem
- Applicant
- Cochlear Americas
- Date received
- 2023-01-20
- Decision date
- 2023-04-24
- Days to decision
- 94 days
- Decision code
- APPR
- Product code
- MHE
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- 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
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