Nucleus® 24 Auditory Brainstem Implant System
FDA premarket approval P000015/S053 · decided 2025-07-03
Approval details
- PMA number
- P000015
- Supplement
- S053
- Supplement type
- Normal 180 Day Track
- 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
- 2024-01-09
- Decision date
- 2025-07-03
- Days to decision
- 541 days
- Decision code
- APPR
- Product code
- MHE
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- 1.A new series of Cochlear Nucleus® Implants: the CI1000 Series implants2.An updated sound processor with accessories: Nucleus® 8 Sound Processor 3.Two new sound processors with accessories: Kanso® 3 Sound Processor compatible with the CI1000 Series implants and Kanso® 3 Sound Processor compatible with commercial CI24RE, CI500 and CI600 Series implants4.A new Surgical Processor compatible with the CI1000 Series implants5.Three updated supporting software devices: Nucleus® SmartNav, Nucleus® Sma
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