MAESTRO System Software 9.0
FDA premarket approval P000025/S124 · decided 2022-05-17
Approval details
- PMA number
- P000025
- Supplement
- S124
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MAESTRO System Software 9.0
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2022-02-17
- Decision date
- 2022-05-17
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- Approval for changes to the MAESTRO System Software 9.
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