NUCLEUS AUDITORY BRAINSTEM IMPLANT SYSTEM
FDA premarket approval P000015/S016 · decided 2017-06-13
Approval details
- PMA number
- P000015
- Supplement
- S016
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NUCLEUS AUDITORY BRAINSTEM IMPLANT SYSTEM
- Generic name
- Implant, auditory brainstem
- Applicant
- Cochlear Americas
- Date received
- 2016-10-12
- Decision date
- 2017-06-13
- Days to decision
- 244 days
- Decision code
- APPR
- Product code
- MHE
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Approval for a new CochlearTM CP1000 Nucleus N7 Sound Processor, which is an external component of the Nucleus 24 Cochlear Implant System, the Nucleus Hybrid L24 Implant System, and the Nucleus Auditory Brainstem Implant System.
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