PMA P130016S051

Device: Nucleus Hybrid L24 Cochlear Implant System
Applicant: Cochlear Americas
PMA number: P130016
Supplement: S051
Product code: PGQ
Decision date: 2022-12-06
Generic name: Cochlear implant with combined electrical stimulation and acoustic amplification
Approval order statement: Approval for the Cochlear Nucleus® MRI Kit, an accessory, together with associated labeling changes, to allow certain Nucleus implant recipients to undergo MRI scans at 1.5 T with the implant magnet in place.

Current openFDA PMA Record#

Device: Nucleus Hybrid L24 Cochlear Implant System
Applicant: Cochlear Americas
PMA number: P130016
Supplement: S051
Product code: PGQ
Generic name: Cochlear implant with combined electrical stimulation and acoustic amplification
Decision date: 2022-12-06
Decision code: APPR
Date received: 2022-09-07
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for the Cochlear Nucleus® MRI Kit, an accessory, together with associated labeling changes, to allow certain Nucleus implant recipients to undergo MRI scans at 1.5 T with the implant magnet in place.