|
Device | Nucleus Auditory Brainstem Implant |
Generic Name | Implant, auditory brainstem |
Applicant | Cochlear Americas 10350 Park Meadows Drive Lone Tree, CO 80124 |
PMA Number | P000015 |
Supplement Number | S047 |
Date Received | 04/26/2022 |
Decision Date | 10/31/2022 |
Product Code |
MHE |
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 for a new sound processor (Nucleus 8 Sound Processor) and two supporting software devices (Custom Sound Pro and Nucleus Smart App) |