Modified indications for use to include adjunctive use in patients with internal or external fracture fixation hardware present, patients undergoing treatment for infection at the fracture site, and patients believed to have diminished bone quality.
| Device | Exogen Ultrasound Bone Healing System |
| Generic Name | Stimulator, Bone Growth, Non-invasive |
| Applicant | BIOVENTUS LLC |
| Date Received | 2019-06-25 |
| Decision Date | 2019-12-20 |
| PMA | P900009 |
| Supplement | S044 |
| Product Code | LOF |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BIOVENTUS LLC 4721 Emperor Blvd Suite 100 durham, NC 27703 |
Supplemental Filings
| 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 |
NIH GUDID Devices