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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceVIBRANT P/ VIBRANT D SOUNDBRIDGE SYSTEM
Generic Nameimplant, hearing, active, middle ear, partially implanted
ApplicantMed-el Elektromedizinische Gerate GmbH
fuerstenweg 77a
a-6020
innsbruck, tirol 
PMA NumberP990052
Date Received09/07/1999
Decision Date08/31/2000
Product Code MPV 
Docket Number 00M-1583
Notice Date 10/27/2000
Advisory Committee Ear Nose & Throat
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE VIBRANT SOUNDBRIDGE SYSTEM. THIS DEVICE IS INDICATED FOR PROVIDING A USEFUL LEVEL OF SOUND PERCEPTION TO INDIVIDUALS VIA MECHANICAL STIMULATINO OF THE OSSICLES. THE VIBRANT SOUNDBRIDGE IS INTENDED FOR USE IN ADULTS, 18 YEARS OF AGE OR OLDER, WHO HAVE A MODERATE TO SEVERE SENSORINEURAL HEARING LOSS AND DESIRE AN ALTERNATIVE TO AN ACOUSTIC HEARING AID. PRIOR TO RECEIVING THE DEVICE, IT IS RECOMMENDED THAT AN INDIVIDUAL HAVE EXPERIENCE WITH APPROPRIATELY FIT HEARING AIDS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements:  S001 S002 S003 S004 S006 S007 S008 S011 S012 S013 S014 
S015 S016 S018 S019 S020 S021 S022 S023 S024 S026 
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