NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
FDA premarket approval P970051/S240 · decided 2025-12-19
Approval details
- PMA number
- P970051
- Supplement
- S240
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2025-11-14
- Decision date
- 2025-12-19
- Days to decision
- 35 days
- Decision code
- OK30
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- to implement an automated electrode welding process, in a controlled non-cleanroom environment, to replace the existing semi-automatic manual welding process for manufacturing electrode arrays in the CI532, CI632, and CI1032 cochlear implants
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