|
Device | Nucleus Hybrid L24 Cochlear Implant System |
Generic Name | Cochlear implant with combined electrical stimulation and acoustic amplification |
Applicant | Cochlear Americas 10350 Park Meadows Drive Centennial, CO 80124 |
PMA Number | P130016 |
Supplement Number | S052 |
Date Received | 03/13/2023 |
Decision Date | 11/17/2023 |
Product Code |
PGQ |
Advisory Committee |
Ear Nose & Throat |
Clinical Trials | NCT02379819
|
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order 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). |