Nucleus Hybrid L24 Implant System
FDA premarket approval P130016/S042 · decided 2020-07-28
Approval details
- PMA number
- P130016
- Supplement
- S042
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Nucleus Hybrid L24 Implant System
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Applicant
- Cochlear Americas
- Date received
- 2020-01-30
- Decision date
- 2020-07-28
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- PGQ
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Approval for PAS Final labeling Extended Follow-up Study.
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