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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 SYSTEM
Classification Nameimplant, hearing, active, middle ear, partially implanted
Generic Nameimplant, hearing, active, middle ear, partially implanted
Applicant
Med-el Elektromedizinische Gerate GmbH
fuerstenweg 77a
a-6020
innsbruck, tirol 
PMA NumberP990052
Supplement NumberS023
Date Received09/27/2013
Decision Date12/19/2013
Product Code
MPV[ Registered Establishments with MPV ]
Advisory Committee Ear Nose & Throat
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A VORP SIZER KIT. THIS INCLUDES A MINOR MODIFICATION (MATERIAL CHANGE) TO THE VORP TEMPLATE AND THE ADDITION OF THE FLOATING MASS TRANSDUCER (FMT) SIZER FOR OPTIONAL USE DURING VIBRANT SOUNDBRIDGE IMPLANTATION SURGERY.
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