PMA P990052S026

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