PMA P000015S048

Device: Nucleus 24 Auditory Brainstem Implant System
Applicant: Cochlear Americas
PMA number: P000015
Supplement: S048
Product code: MHE
Decision date: 2022-12-06
Generic name: Implant, auditory brainstem
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 24 Auditory Brainstem Implant System
Applicant: Cochlear Americas
PMA number: P000015
Supplement: S048
Product code: MHE
Generic name: Implant, auditory brainstem
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.