Nucleus Hybrid L24 Cochlear Implant System
FDA premarket approval P130016/S052 · decided 2023-11-17
Approval details
- PMA number
- P130016
- Supplement
- S052
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Nucleus Hybrid L24 Cochlear Implant System
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Applicant
- Cochlear Americas
- Date received
- 2023-03-13
- Decision date
- 2023-11-17
- Days to decision
- 249 days
- Decision code
- APPR
- Product code
- PGQ
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Approval for modification of the approved labeling for the Nucleus® Hybrid L24 Cochlear Implant System to reflect the findings of the Post-Approval Study: New Enrollment Study (P130016/PAS002).
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