SONNET 2, SONNET 2 EAS, RONDO 3, MAESTRO 8, and MAESTRO 9
FDA premarket approval P000025/S120 · decided 2021-06-25
Approval details
- PMA number
- P000025
- Supplement
- S120
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SONNET 2, SONNET 2 EAS, RONDO 3, MAESTRO 8, and MAESTRO 9
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2020-09-28
- Decision date
- 2021-06-25
- Days to decision
- 270 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- Approval for Front-End Signal Processing Features: Ambient Noise Reduction, Transient Noise Reduction and Adaptive Intelligence.
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