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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
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 NumberS006
Date Received09/24/2001
Decision Date10/26/2001
Product Code
MPV[ Registered Establishments with MPV ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR DESIGN CHANGES TO THE AUDIO PROCESSOR MODEL 404. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VIBRANT(R) SOUNDBRIDGE(TM) AUDIO PROCESSOR MODEL 404SR. THE INDICATIONS FOR USE FOR THE DEVICE HAVE NOT CHANGED.
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