Nucleus Auditory Brainstem Implant System
FDA premarket approval P000015/S023 · decided 2017-09-20
Approval details
- PMA number
- P000015
- Supplement
- S023
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Nucleus Auditory Brainstem Implant System
- Generic name
- Implant, auditory brainstem
- Applicant
- Cochlear Americas
- Date received
- 2017-06-21
- Decision date
- 2017-09-20
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- MHE
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Approval for an update to the Cochlear Integrity Test System version 1.4 to version 1.5. The update to version 1.5 from 1.4 is a minor software change that includes 1) the addition of a dropdown box for Cochlear employees to select the CI532 with Slim Modiolar Electrode from the suite of compatible implants; and 2) a revision to the stimulation safety limits.
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