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 modification to the mounting of the electronic module assembly, the microphone and the programming socket; change in the physical shape of the magnet from a notched-shape to a full round shape; change in the material of the tip cover of the audio processor (ap) to acrylonitrile-butadiene-styrene copolymer (abs) and addition of three different colors (light brown, brown and gray) to better match the hair colors of the final users; and pictorial and text changes to reflect the new shape and color of the ap in reference manual for audiologists and patient user manual.
| Device | VIBRANT 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 | 2001-06-20 |
| Decision Date | 2001-07-24 |
| PMA | P990052 |
| Supplement | S004 |
| Product Code | MPV |
| Advisory Committee | Ear Nose & Throat |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |