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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 SYSTEM
Classification Nameimplant, hearing, active, middle ear, partially implanted
Generic Nameimplantable middle ear hearing device
ApplicantSYMPHONIX DEVICES, INC.
PMA NumberP990052
Supplement NumberS006
Date Received09/24/2001
Decision Date10/26/2001
Product Code
MPV[ Registered Establishments with MPV ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for design changes to the audio processor model 404. The device, as modified, will be marketed under the trade name vibrant(r) soundbridge(tm) audio processor model 404sr. The indications for use for the device have not changed.
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