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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 MIDDLE EAR IMPLANT SYSTEM
Generic NameImplant, hearing, active, middle ear, partially implanted
ApplicantMed-El Elektromedizinische Gerate GmbH
Fuerstenweg 77a
Innsbruck A-6020
PMA NumberP990052
Supplement NumberS012
Date Received12/01/2005
Decision Date10/13/2006
Product Code MPV 
Advisory Committee Ear Nose & Throat
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT MED-EL ELEKTROMEDIZINISCHE GERATE (CONTRACT MANUFACTURER FOR VIBRANT MED-EL) GMBH OF INNSBRUCK, AUSTRIA, FOR THE LASER WELDING OF THE PRE WELDED DEMODULATOR UNIT AND THE BOBBIN.
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