|
Device | Nucleus Hybrid L24 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 | S042 |
Date Received | 01/30/2020 |
Decision Date | 07/28/2020 |
Product Code |
PGQ |
Advisory Committee |
Ear Nose & Throat |
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 PAS Final labeling Extended Follow-up Study. |