NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT (ABI)
FDA premarket approval P000015/S005 · decided 2003-08-22
Approval details
- PMA number
- P000015
- Supplement
- S005
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT (ABI)
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2003-06-24
- Decision date
- 2003-08-22
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- 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.
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