PMA P970051S207

Device: Nucleus 24 Cochlear Implant System
Applicant: Cochlear Americas
PMA number: P970051
Supplement: S207
Product code: MCM
Decision date: 2021-10-08
Generic name: Implant, cochlear
Approval order statement: Approval for a Remote Assist, a new software feature intended to enable clinicians to make select programming adjustments, enable processor settings, and provide counselling via a live video session with their cochlear implant patients.

Current openFDA PMA Record#

Device: Nucleus 24 Cochlear Implant System
Applicant: Cochlear Americas
PMA number: P970051
Supplement: S207
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2021-10-08
Decision code: APPR
Date received: 2021-07-13
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a Remote Assist, a new software feature intended to enable clinicians to make select programming adjustments, enable processor settings, and provide counselling via a live video session with their cochlear implant patients.