Nucleus® Hybrid Implant System
FDA premarket approval P130016/S046 · decided 2022-04-29
Approval details
- PMA number
- P130016
- Supplement
- S046
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Nucleus® Hybrid Implant System
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Applicant
- Cochlear Americas
- Date received
- 2022-01-31
- Decision date
- 2022-04-29
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- PGQ
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Approval for modification to Cochlear Research Platform Software resulting in version 2.0 of the software. This software update makes minor performance changes to existing electrocochleography functionality and implements a new software design to allow for introduction of future functionality.
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