24 Cochlear Implant System
FDA premarket approval P970051/S200 · decided 2020-12-30
Approval details
- PMA number
- P970051
- Supplement
- S200
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- 24 Cochlear Implant System
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2020-10-02
- Decision date
- 2020-12-30
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Approval for a new in-house terminal sterilization process to be used with a new sterilizer.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.