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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 P SOUNDBRIDGE/VIBRANT D SOUNDBRIDGE SYSTEM
Classification Nameimplant, hearing, active, middle ear, partially implanted
Generic Nameimplantable middle ear hearing device
ApplicantSYMPHONIX DEVICES, INC.
PMA NumberP990052
Supplement NumberS001
Date Received09/12/2000
Decision Date09/21/2000
Product Code
MPV[ Registered Establishments with MPV ]
Advisory Committee Ear Nose & Throat
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for incorporation of a releasable battery door for the audio processor d (model 304).
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