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Device | Nucleus ABI541 Auditory Brainstem Implant |
Generic Name | Implant, auditory brainstem |
Applicant | Cochlear Americas 10350 Park Meadows Drive Lone Tree, CO 80124 |
PMA Number | P000015 |
Supplement Number | S034 |
Date Received | 11/01/2018 |
Decision Date | 06/05/2019 |
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 Approval order should be issued for new accessories and modifications to the firmware and software of the Nucleus 7 system, as well as a research tool named the Cochlear Research Platform. |