PMA P000025S086
- Device
- COMBI 40+ COCHLEAR IMPLANT SYSTEM
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S086
- Product code
- MCM
- Decision date
- 2016-05-11
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- Approval for the optional protection covering accessory called the WaterWear for SONNET or OPUS 2 behind-the-ear (BTE) audio processors.
Current openFDA PMA Record#
- Device
- COMBI 40+ COCHLEAR IMPLANT SYSTEM
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S086
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2016-05-11
- Decision code
- APPR
- Date received
- 2016-02-11
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the optional protection covering accessory called the WaterWear for SONNET or OPUS 2 behind-the-ear (BTE) audio processors.