PMA P000015S046

Device: Nucleus® Auditory Brainstem Implant System
Applicant: Cochlear Americas
PMA number: P000015
Supplement: S046
Product code: MHE
Decision date: 2021-12-07
Generic name: Implant, auditory brainstem
Approval order statement: Approval for the introduction of an alternative supplier for components of the following implant devices: CI512, CI522, CI532, ABI541, CI612, CI622, CI624, and CI632.

Current openFDA PMA Record#

Device: Nucleus® Auditory Brainstem Implant System
Applicant: Cochlear Americas
PMA number: P000015
Supplement: S046
Product code: MHE
Generic name: Implant, auditory brainstem
Decision date: 2021-12-07
Decision code: APPR
Date received: 2021-06-21
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the introduction of an alternative supplier for components of the following implant devices: CI512, CI522, CI532, ABI541, CI612, CI622, CI624, and CI632.