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.
Change to the sterilization process parameters for the vibrant soundbridge vibrating ossicular prosthesis implant.
| Device | VIBRANT SOUNDBRIDGE MIDDLE EAR IMPLANT 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 | 2007-05-14 |
| Decision Date | 2007-06-13 |
| PMA | P990052 |
| Supplement | S018 |
| Product Code | MPV |
| Advisory Committee | Ear Nose & Throat |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |