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.
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.
| Device | VIBRANT P/ VIBRANT D SOUNDBRIDGE SYSTEM |
| Classification Name | Implant, Hearing, Active, Middle Ear, Partially Implanted |
| Generic Name | Implant, Hearing, Active, Middle Ear, Partially Implanted |
| Applicant | Med-el Elektromedizinische Gerate GmbH |
| Date Received | 1999-09-07 |
| Decision Date | 2000-08-31 |
| Notice Date | 2000-10-27 |
| PMA | P990052 |
| Supplement | S |
| Product Code | MPV |
| Docket Number | 00M-1583 |
| Advisory Committee | Ear Nose & Throat |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Med-el Elektromedizinische Gerate GmbH fuerstenweg 77a a-6020 innsbruck, Tirol |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990052 | Original Filing | |
| S026 | 2022-07-14 | Real-time Process |
| S025 | ||
| S024 | 2013-12-20 | 30-day Notice |
| S023 | 2013-09-27 | Real-time Process |
| S022 | 2009-11-16 | Normal 180 Day Track |
| S021 | 2008-09-24 | 30-day Notice |
| S020 | 2008-08-22 | Normal 180 Day Track No User Fee |
| S019 | 2008-01-22 | Real-time Process |
| S018 | 2007-05-14 | 30-day Notice |
| S017 | ||
| S016 | 2007-02-28 | 30-day Notice |
| S015 | 2006-11-24 | Real-time Process |
| S014 | 2006-11-13 | 30-day Notice |
| S013 | 2006-07-12 | 135 Review Track For 30-day Notice |
| S012 | 2005-12-01 | Normal 180 Day Track No User Fee |
| S011 | 2004-04-08 | Normal 180 Day Track No User Fee |
| S010 | ||
| S009 | ||
| S008 | 2002-05-01 | Normal 180 Day Track |
| S007 | 2002-02-01 | Real-time Process |
| S006 | 2001-09-24 | Normal 180 Day Track |
| S005 | ||
| S004 | 2001-06-20 | Real-time Process |
| S003 | 2001-03-09 | Normal 180 Day Track |
| S002 | 2000-11-03 | Normal 180 Day Track |
| S001 | 2000-09-12 | Real-time Process |