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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 NumberS004
Date Received06/20/2001
Decision Date07/24/2001
Product Code
MPV[ Registered Establishments with MPV ]
Advisory Committee Ear Nose & Throat
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modification to the mounting of the electronic module assembly, the microphone and the programming socket; change in the physical shape of the magnet from a notched-shape to a full round shape; change in the material of the tip cover of the audio processor (ap) to acrylonitrile-butadiene-styrene copolymer (abs) and addition of three different colors (light brown, brown and gray) to better match the hair colors of the final users; and pictorial and text changes to reflect the new shape and color of the ap in reference manual for audiologists and patient user manual.
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