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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 NumberS008
Date Received05/01/2002
Decision Date07/02/2002
Product Code
MPV[ Registered Establishments with MPV ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR CHANGES TO THE MANUFACTURING SPECIFICATION CRITERIA FOR THE FLOATING MASS TRANSDUCER.
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