Nucleus® 24 Cochlear Implant System
FDA premarket approval P970051/S212 · decided 2022-09-26
Approval details
- PMA number
- P970051
- Supplement
- S212
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Nucleus® 24 Cochlear Implant System
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2022-06-28
- Decision date
- 2022-09-26
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Approval for modifications to the Nucleus SmartNav System resulting in version 2.0 of the software.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.