SONNET 3 (EAS) Audio Processor, MAESTRO 11
FDA premarket approval P000025/S131 · decided 2025-02-13
Approval details
- PMA number
- P000025
- Supplement
- S131
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SONNET 3 (EAS) Audio Processor, MAESTRO 11
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2024-06-28
- Decision date
- 2025-02-13
- Days to decision
- 230 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- Approval for the SONNET 3 (EAS) Audio Processor and MAESTRO 11.
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