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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameVIBRANT SOUNDBRIDGE MIDDLE EAR IMPLANT SYSTEM
Classification Nameimplant, hearing, active, middle ear, partially implanted
Generic Nameimplantable middle ear hearing device
ApplicantVIBRANT MED-EL HEARING TECHNOLOGY GMBH
PMA NumberP990052
Supplement NumberS012
Date Received12/01/2005
Decision Date10/13/2006
Product Code
MPV[ Registered Establishments with MPV ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track no user fee
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
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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