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.
Alternate supplier.
| Device | EXOGEN ULTRASOUND BONE HEALING SYSTEM |
| Classification Name | Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep |
| Generic Name | Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep |
| Applicant | BIOVENTUS LLC |
| Date Received | 2015-03-02 |
| Decision Date | 2015-04-22 |
| PMA | P900009 |
| Supplement | S039 |
| Product Code | LPQ |
| Advisory Committee | Orthopedic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |