Nucleus® 24 Auditory Brainstem Implant System
FDA premarket approval P000015/S050 · decided 2023-10-13
Approval details
- PMA number
- P000015
- Supplement
- S050
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Nucleus® 24 Auditory Brainstem Implant System
- Generic name
- Implant, auditory brainstem
- Applicant
- Cochlear Americas
- Date received
- 2023-09-15
- Decision date
- 2023-10-13
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- MHE
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- approval for a labeling change to the Cochlear Nucleus MRI Kit
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.