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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceVIBRANT SOUNDBRIDGE SYSTEM
Classification Nameimplant, hearing, active, middle ear, partially implanted
Generic Nameimplant, hearing, active, middle ear, partially implanted
Applicant
Med-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[ Registered Establishments with MPV ]
Advisory Committee Ear Nose & Throat
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
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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