Nucleus® Hybrid L24 Cochlear Implant System
FDA premarket approval P130016/S053 · decided 2023-10-13
Approval details
- PMA number
- P130016
- Supplement
- S053
- 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
- 2023-09-15
- Decision date
- 2023-10-13
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- PGQ
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- approval for a labeling change to the Cochlear Nucleus MRI Kit
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