|
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 | S042 |
Date Received | 11/13/2019 |
Decision Date | 12/13/2019 |
Product Code |
MHE |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Manufacturing change of the silicone overmoulding used in the CI500 Series Cochlear Implant and the ABI541 Auditory Brainstem Implant. |