|
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 | S050 |
Date Received | 09/15/2023 |
Decision Date | 10/13/2023 |
Product Code |
MHE |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement approval for a labeling change to the Cochlear Nucleus MRI Kit |