MED-EL Cochlear Implant System
FDA premarket approval P000025/S116 · decided 2020-08-25
Approval details
- PMA number
- P000025
- Supplement
- S116
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MED-EL Cochlear Implant System
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2020-05-27
- Decision date
- 2020-08-25
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- Approval for the RONDO 3 Audio Processor, MAESTRO System Software 9.0, and WaterWear for RONDO 3.
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