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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 IMPLANTABLE MIDDLE EAR HEARING DEVICE (IMEHD)
Generic NameImplant, hearing, active, middle ear, partially implanted
ApplicantMed-El Elektromedizinische Gerate GmbH
Fuerstenweg 77a
Innsbruck A-6020
PMA NumberP990052
Supplement NumberS016
Date Received02/28/2007
Decision Date03/30/2007
Product Code MPV 
Advisory Committee Ear Nose & Throat
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
UPDATE TO THE SHELF-LIFE INFORMATION OF THE SILICONE RUBBERS AND EPOXIES AND CHANGE TO THE COATING OF THE AUDIO PROCESSOR (AP) MAGNETS FROM ALUMINUM CHROMATE IV TO ALUMINUM PHOSPHATE.
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