PMA P000015S023

Device: Nucleus Auditory Brainstem Implant System
Applicant: Cochlear Americas
PMA number: P000015
Supplement: S023
Product code: MHE
Decision date: 2017-09-20
Classification: Implant, Auditory Brainstem
Generic name: Implant, auditory brainstem
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.

Current openFDA PMA Record#

Device: Nucleus Auditory Brainstem Implant System
Applicant: Cochlear Americas
PMA number: P000015
Supplement: S023
Product code: MHE
Generic name: Implant, auditory brainstem
Decision date: 2017-09-20
Decision code: APPR
Date received: 2017-06-21
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
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.