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.
| Device | SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A |
| Classification Name | Stimulator, Bone Growth, Non-invasive |
| Generic Name | Stimulator, Bone Growth, Non-invasive |
| Applicant | BIOVENTUS LLC |
| Date Received | 1990-02-01 |
| Decision Date | 1994-10-05 |
| Notice Date | 1994-11-09 |
| PMA | P900009 |
| Supplement | S |
| Product Code | LOF |
| Docket Number | 94M-0363 |
| Advisory Committee | Orthopedic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BIOVENTUS LLC 4721 Emperor Blvd Suite 100 durham, NC 27703 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P900009 | Original Filing | |
| S048 | 2021-12-03 | 30-day Notice |
| S047 | 2021-05-25 | Normal 180 Day Track |
| S046 | 2021-03-16 | 30-day Notice |
| S045 | ||
| S044 | 2019-06-25 | Normal 180 Day Track |
| S043 | 2018-04-30 | 30-day Notice |
| S042 | 2017-08-14 | 30-day Notice |
| S041 | 2016-12-13 | 30-day Notice |
| S040 | ||
| S039 | 2015-03-02 | 30-day Notice |
| S038 | 2014-11-17 | 30-day Notice |
| S037 | 2014-07-22 | 30-day Notice |
| S036 | 2013-08-22 | Normal 180 Day Track No User Fee |
| S035 | 2013-07-15 | Normal 180 Day Track |
| S034 | ||
| S033 | 2012-05-09 | 30-day Notice |
| S032 | 2010-02-24 | 30-day Notice |
| S031 | 2009-06-09 | Normal 180 Day Track No User Fee |
| S030 | 2008-12-23 | 135 Review Track For 30-day Notice |
| S029 | 2008-11-28 | 30-day Notice |
| S028 | 2007-07-20 | 30-day Notice |
| S027 | 2007-07-10 | Real-time Process |
| S026 | ||
| S025 | 2007-02-22 | 135 Review Track For 30-day Notice |
| S024 | 2006-10-02 | 30-day Notice |
| S023 | 2006-05-15 | Real-time Process |
| S022 | 2005-12-16 | Normal 180 Day Track |
| S021 | 2005-08-01 | Normal 180 Day Track |
| S020 | 2005-04-29 | 30-day Notice |
| S019 | 2004-03-05 | Real-time Process |
| S018 | 2004-01-29 | Real-time Process |
| S017 | 2003-03-03 | Special (immediate Track) |
| S016 | 2002-12-20 | Real-time Process |
| S015 | 2001-12-13 | Normal 180 Day Track |
| S014 | 2001-12-07 | Real-time Process |
| S013 | 2001-04-30 | Normal 180 Day Track |
| S012 | 2000-10-12 | Normal 180 Day Track |
| S011 | 2000-07-11 | Normal 180 Day Track |
| S010 | 2000-04-14 | Real-time Process |
| S009 | 2000-04-03 | Normal 180 Day Track |
| S008 | 1999-10-27 | Normal 180 Day Track |
| S007 | 1999-07-07 | Real-time Process |
| S006 | 1998-07-02 | Panel Track |
| S005 | ||
| S004 | ||
| S003 | 1996-01-02 | Normal 180 Day Track |
| S002 | 1995-12-15 | Normal 180 Day Track |
| S001 | 1995-02-14 | Normal 180 Day Track |
| Device ID | PMA | Supp |
|---|---|---|
| M937710346001 | P900009 | 022 |
| M937710344001 | P900009 | 035 |
| M937710346601 | P900009 | 035 |