PMA P000025S116
- Device
- MED-EL Cochlear Implant System
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S116
- Product code
- MCM
- Decision date
- 2020-08-25
- Generic name
- Implant, cochlear
- Approval order statement
- Approval for the RONDO 3 Audio Processor, MAESTRO System Software 9.0, and WaterWear for RONDO 3.
Current openFDA PMA Record#
- Device
- MED-EL Cochlear Implant System
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S116
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2020-08-25
- Decision code
- APPR
- Date received
- 2020-05-27
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the RONDO 3 Audio Processor, MAESTRO System Software 9.0, and WaterWear for RONDO 3.