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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.
 
DeviceVIBRANT SOUNDBRIDGE DIRECT DRIVE DEMONSTRATOR
Classification Nameimplant, hearing, active, middle ear, partially implanted
Generic Nameimplant, hearing, active, middle ear, partially implanted
Applicant
VIBRANT MED-EL HEARING TECHNOLOGY GMBH
fuerstenweg 77
a-6020
innsbruck 
PMA NumberP990052
Supplement NumberS007
Date Received02/01/2002
Decision Date04/17/2002
Product Code
MPV[ Registered Establishments with MPV ]
Advisory Committee Ear Nose & Throat
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of the direct drive demonstrator to the vibrant soundbridge system. The device, as modified, will be marketed under the trade name vibrant soundbridge direct drive demonstrator. The indications for use for the device have not changed.
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