NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM
FDA premarket approval P000015 · decided 2000-10-20
Approval details
- PMA number
- P000015
- Trade name
- NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM
- Generic name
- Implant, auditory brainstem
- Applicant
- Cochlear Americas
- Date received
- 2000-03-29
- Decision date
- 2000-10-20
- Days to decision
- 205 days
- Decision code
- APPR
- Product code
- MHE
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- Yes
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR THE NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT (ABI) SYSTEM, WHICH IS INTENDED TO RESTORE USEFUL HEARING VIA ELECTRICAL STIMULATION OF THE COCHLEAR NUCLEUS. THE DEVICE IS INDICATED FOR INDIVIDUALS 12 YEARS OF AGE OR OLDER, WHO HAVE BEEN DIAGNOSED WITH NEUROFIBROMATOSIS TYPE 2 (NF2). IMPLANTATION MAY OCCUR DURING FIRST OR SECOND-SIDE TUMOR REMOVAL, OR IN PATIENTS WITH PREVIOUSLY REMOVED ACOUSTIC TUMORS BILATERALLY. BECAUSE THE SURGICAL PROCEDURE FOR TUMOR EXCISION AND ELECTRODE PLACEMENT
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