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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 NumberS004
Date Received06/20/2001
Decision Date07/24/2001
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  
APPROVAL FOR MODIFICATION TO THE MOUNTING OF THE ELECTRONIC MODULE ASSEMBLY, THE MICROPHONE AND THE PROGRAMMING SOCKET; CHANGE IN THE PHYSICAL SHAPE OF THE MAGNET FROM A NOTCHED-SHAPE TO A FULL ROUND SHAPE; CHANGE IN THE MATERIAL OF THE TIP COVER OF THE AUDIO PROCESSOR (AP) TO ACRYLONITRILE-BUTADIENE-STYRENE COPOLYMER (ABS) AND ADDITION OF THREE DIFFERENT COLORS (LIGHT BROWN, BROWN AND GRAY) TO BETTER MATCH THE HAIR COLORS OF THE FINAL USERS; AND PICTORIAL AND TEXT CHANGES TO REFLECT THE NEW SHAPE AND COLOR OF THE AP IN REFERENCE MANUAL FOR AUDIOLOGISTS AND PATIENT USER MANUAL.
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