HearCare MED-EL, MAESTRO System Software 10.0
FDA premarket approval P000025/S126 · decided 2023-11-05
Approval details
- PMA number
- P000025
- Supplement
- S126
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HearCare MED-EL, MAESTRO System Software 10.0
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2023-08-07
- Decision date
- 2023-11-05
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- HearCare App and MAESTRO System Software 10.0
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