|
Device | Nucleus Hybrid Implant System |
Generic Name | Cochlear implant with combined electrical stimulation and acoustic amplification |
Applicant | Cochlear Americas 10350 Park Meadows Drive Centennial, CO 80124 |
PMA Number | P130016 |
Supplement Number | S030 |
Date Received | 06/21/2017 |
Decision Date | 09/20/2017 |
Product Code |
PGQ |
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 an update to the Cochlear Integrity Test System version 1.4 to version 1.5. The update to version 1.5 from 1.4 is a minor software change that includes 1) the addition of a dropdown box for Cochlear employees to select the CI532 with Slim Modiolar Electrode from the suite of compatible implants; and 2) a revision to the stimulation safety limits. |