|
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 | S032 |
Date Received | 11/13/2017 |
Decision Date | 06/13/2018 |
Product Code |
PGQ |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the modifications to the firmware and software of the Nucleus 7 system as well as a modification to the Custom Sound EP used with the Nucleus 6 system. |