NUCLEUS ABI541 AUDITORY BRAINSTEM IMPLANT
FDA premarket approval P000015/S012 · decided 2016-06-13
Approval details
- PMA number
- P000015
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NUCLEUS ABI541 AUDITORY BRAINSTEM IMPLANT
- Generic name
- Implant, auditory brainstem
- Applicant
- Cochlear Americas
- Date received
- 2015-12-18
- Decision date
- 2016-06-13
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- MHE
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Approval for the Nucleus ABI541 Auditory Brainstem Implant, a modification to the existing ABI24M device, which is intended to restore a level of auditory sensation via electrical stimulation of the cochlear nucleus in 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
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