|
Device | Necleus Auditory Brainstem Impant System |
Generic Name | Implant, auditory brainstem |
Applicant | Cochlear Americas 10350 Park Meadows Drive Lone Tree, CO 80124 |
PMA Number | P000015 |
Supplement Number | S025 |
Date Received | 08/07/2017 |
Decision Date | 09/05/2017 |
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 Introduction of an additional quality control step after the coil and hardball welding operation of the CI500 series implants. |