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.

Device	VIBRANT P/ VIBRANT D SOUNDBRIDGE SYSTEM
Generic Name	Implant, hearing, active, middle ear, partially implanted
Applicant	Med-el Elektromedizinische Gerate GmbH FUERSTENWEG 77A A-6020 INNSBRUCK, TIROL
PMA Number	P990052
Date Received	09/07/1999
Decision Date	08/31/2000
Product Code	MPV
Docket Number	00M-1583
Notice Date	10/27/2000
Advisory Committee	Ear Nose & Throat
Expedited Review Granted?	No
Combination Product	No
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 Order	Approval Order
Summary	Summary of Safety and Effectiveness
Labeling	Labeling 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