| 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. |
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| Device | VIBRANT P/ VIBRANT D SOUNDBRIDGE SYSTEM |
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| Generic Name | Implant, hearing, active, middle ear, partially implanted |
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| Applicant | Med-el Elektromedizinische Gerate GmbH
FUERSTENWEG 77A
A-6020
INNSBRUCK, TIROL |
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| PMA Number | P990052 |
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| Date Received | 09/07/1999 |
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| Decision Date | 08/31/2000 |
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| Product Code |
MPV |
| Docket Number | 00M-1583 |
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| Notice Date | 10/27/2000 |
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| Advisory Committee |
Ear Nose & Throat |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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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 |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
Labeling Part 2 |
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| Supplements: |
S003 S024 S012 S018 S008 S004 S006 S011 S020 S013 S002
S001 S023 S019 S014 S015 S021 S007 S016 S022 S026 |
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