PMA P000015S005

Device: NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT (ABI)
Applicant: Cochlear Americas
PMA number: P000015
Supplement: S005
Product code: MCM
Decision date: 2003-08-22
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR THE ADDITION OF A POLYTEREPHTHALATE (PET) MESH DISK. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT WITH PET MESH DISK AND IS INTENDED TO RESTORE USEFUL HEARING IN INDIVIDUALS WITH NEUROFIBROMATOSIS TYPE 2 (NF2) WHO ARE 12 YEARS OF AGE OR OLDER, VIA ELECTRICAL STIMULATION OF THE COCHLEAR NUCLEUS.

Current openFDA PMA Record#

Device: NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT (ABI)
Applicant: Cochlear Americas
PMA number: P000015
Supplement: S005
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2003-08-22
Decision code: APPR
Date received: 2003-06-24
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE ADDITION OF A POLYTEREPHTHALATE (PET) MESH DISK. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT WITH PET MESH DISK AND IS INTENDED TO RESTORE USEFUL HEARING IN INDIVIDUALS WITH NEUROFIBROMATOSIS TYPE 2 (NF2) WHO ARE 12 YEARS OF AGE OR OLDER, VIA ELECTRICAL STIMULATION OF THE COCHLEAR NUCLEUS.