Nucleus Hybrid L24 Implant System
FDA premarket approval P130016/S032 · decided 2018-06-13
Approval details
- PMA number
- P130016
- Supplement
- S032
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Nucleus Hybrid L24 Implant System
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Applicant
- Cochlear Americas
- Date received
- 2017-11-13
- Decision date
- 2018-06-13
- Days to decision
- 212 days
- Decision code
- APPR
- Product code
- PGQ
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Approval for the modifications to the firmware and software of the Nucleus 7 system as well as a modification to the Custom Sound EP used with the Nucleus 6 system.
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