|
Device | Nucleus 24 Auditory Brainstem Implant System |
Generic Name | Implant, auditory brainstem |
Applicant | Cochlear Americas 10350 Park Meadows Drive Lone Tree, CO 80124 |
PMA Number | P000015 |
Supplement Number | S049 |
Date Received | 01/20/2023 |
Decision Date | 04/24/2023 |
Product Code |
MHE |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for changes to the material and design of the coil crimp and its joining process used in the CI500 Series & CI600 Series Cochlear Implants and the ABI541 Auditory Brainstem Implant |