Nucleus Hybrid Cochlear Implant
FDA premarket approval P130016/S039 · decided 2020-04-02
Approval details
- PMA number
- P130016
- Supplement
- S039
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Nucleus Hybrid Cochlear Implant
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Applicant
- Cochlear Americas
- Date received
- 2019-07-31
- Decision date
- 2020-04-02
- Days to decision
- 246 days
- Decision code
- APPR
- Product code
- PGQ
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Approval for Remote Check, a clinician-enabled option for the Nucleus Smart App, that allows clinicians to monitor the performance of the associated implant system remotely.
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