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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceVibrant Soundbridge System
Generic NameImplant, hearing, active, middle ear, partially implanted
ApplicantMed-el Elektromedizinische Gerate GmbH
FUERSTENWEG 77A
A-6020
INNSBRUCK, TIROL 
PMA NumberP990052
Supplement NumberS026
Date Received07/14/2022
Decision Date10/11/2022
Product Code MPV 
Advisory Committee Ear Nose & Throat
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
the SAMBA 2 VSB audio processor and the supporting SYMFIT 8.0.1 fitting software
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