PMA P000025S099
- Device
- RONDO 2 Audio Processor & WaterWear for RONDO 2
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S099
- Product code
- MCM
- Decision date
- 2018-05-15
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- Approval for the RONDO 2 Audio Processor and WaterWear for RONDO 2.
Current openFDA PMA Record#
- Device
- RONDO 2 Audio Processor & WaterWear for RONDO 2
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S099
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2018-05-15
- Decision code
- APPR
- Date received
- 2018-02-14
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the RONDO 2 Audio Processor and WaterWear for RONDO 2.