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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 P SOUNDBRIDGE/VIBRANT D SOUNDBRIDGE SYSTEM
Generic NameImplant, hearing, active, middle ear, partially implanted
ApplicantMed-el Elektromedizinische Gerate GmbH
FUERSTENWEG 77A
A-6020
INNSBRUCK, TIROL 
PMA NumberP990052
Supplement NumberS001
Date Received09/12/2000
Decision Date09/21/2000
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 INCORPORATION OF A RELEASABLE BATTERY DOOR FOR THE AUDIO PROCESSOR D (MODEL 304).
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