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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
Generic NameImplant, hearing, active, middle ear, partially implanted
ApplicantMed-El Elektromedizinische Gerate GmbH
Fuerstenweg 77a
Innsbruck A-6020
PMA NumberP990052
Supplement NumberS015
Date Received11/24/2006
Decision Date12/13/2006
Product Code MPV 
Advisory Committee Ear Nose & Throat
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE IN THE WORDING OF THE INDICATIONS FOR USE STATEMENT AND A NEW PRODUCT CODE DESCRIPTION THAT REMOVES THE REFERENCE TO HEARING AIDS. THE DEVICE IS INDICATED FOR USE IN ADULTS, 18 YEARS OF AGE OR OLDER, WHO HAVE A MODERATE TO SEVERE SENSORINEURAL HEARING LOSS. PRIOR TO RECEIVING THE DEVICE, IT IS RECOMMENDED THAT AN INDIVIDUAL HAVE EXPERIENCE WITH APPROPRIATELY FIT HEARING AIDS.
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