PMA P000025S120
- Device
- SONNET 2, SONNET 2 EAS, RONDO 3, MAESTRO 8, and MAESTRO 9
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S120
- Product code
- MCM
- Decision date
- 2021-06-25
- Generic name
- Implant, cochlear
- Approval order statement
- Approval for Front-End Signal Processing Features: Ambient Noise Reduction, Transient Noise Reduction and Adaptive Intelligence.
Current openFDA PMA Record#
- Device
- SONNET 2, SONNET 2 EAS, RONDO 3, MAESTRO 8, and MAESTRO 9
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S120
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2021-06-25
- Decision code
- APPR
- Date received
- 2020-09-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for Front-End Signal Processing Features: Ambient Noise Reduction, Transient Noise Reduction and Adaptive Intelligence.