Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | Nucleus 24 Cochlear Implant System |
Generic Name | Implant, cochlear |
Applicant | Cochlear Americas 10350 Park Meadows Drive Lone Tree, CO 80124 |
PMA Number | P970051 |
Supplement Number | S217 |
Date Received | 01/20/2023 |
Decision Date | 04/24/2023 |
Product Code |
MCM |
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 |
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