Nucleus 24 Cochlear Implant System
FDA premarket approval P970051/S207 · decided 2021-10-08
Approval details
- PMA number
- P970051
- Supplement
- S207
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Nucleus 24 Cochlear Implant System
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2021-07-13
- Decision date
- 2021-10-08
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Approval for a Remote Assist, a new software feature intended to enable clinicians to make select programming adjustments, enable processor settings, and provide counselling via a live video session with their cochlear implant patients.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.