PMA P990052
- Device
- Vibrant Soundbridge System
- Applicant
- Med-El Elektromedizinische Gerate GmbH
- PMA number
- P990052
- Supplement
- S026
- Product code
- MPV
- Decision date
- 2022-10-11
- Generic name
- Implant, hearing, active, middle ear, partially implanted
- Approval order statement
- the SAMBA 2 VSB audio processor and the supporting SYMFIT 8.0.1 fitting software
Current openFDA PMA Record#
- Device
- Vibrant Soundbridge System
- Applicant
- Med-El Elektromedizinische Gerate GmbH
- PMA number
- P990052
- Supplement
- S026
- Product code
- MPV
- Generic name
- Implant, hearing, active, middle ear, partially implanted
- Decision date
- 2022-10-11
- Decision code
- APPR
- Date received
- 2022-07-14
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- the SAMBA 2 VSB audio processor and the supporting SYMFIT 8.0.1 fitting software