Nucleus Hybrid L24 Implant System
FDA premarket approval P130016/S049 · decided 2022-06-16
Approval details
- PMA number
- P130016
- Supplement
- S049
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Nucleus Hybrid L24 Implant System
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Applicant
- Cochlear Americas
- Date received
- 2022-05-02
- Decision date
- 2022-06-16
- Days to decision
- 45 days
- Decision code
- APPR
- Product code
- PGQ
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
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