This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for a change in the wording of the indications for use statement and a new product code description that removes the reference to hearing aids. The device is indicated for use in adults, 18 years of age or older, who have a moderate to severe sensorineural hearing loss. Prior to receiving the device, it is recommended that an individual have experience with appropriately fit hearing aids.
| Device | VIBRANT SOUNDBRIDGE |
| 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 | 2006-11-24 |
| Decision Date | 2006-12-13 |
| PMA | P990052 |
| Supplement | S015 |
| Product Code | MPV |
| Advisory Committee | Ear Nose & Throat |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Med-el Elektromedizinische Gerate GmbH fuerstenweg 77a a-6020 innsbruck, Tirol |
| 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 |