Nucleus Hybrid L24 Cochlear Implant System
FDA premarket approval P130016/S043 · decided 2020-02-21
Approval details
- PMA number
- P130016
- Supplement
- S043
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Nucleus Hybrid L24 Cochlear Implant System
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Applicant
- Cochlear Americas
- Date received
- 2020-01-14
- Decision date
- 2020-02-21
- Days to decision
- 38 days
- Decision code
- APPR
- Product code
- PGQ
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Approval for changes to MR Conditional labeling for CI24REH, CI24RE and CI500 Series Cochlear Implants.
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