Approval for a change in labeling for the exogen 3000(r), to incorporate both the fresh fracture and nonunion information into one set of physician's instructions for use, patient's instructions for use, and product insert bulletin; to make manual size and formatting changes, and to add nonunion background information.
| Device | EXOGEN 3000 SONIC ACCELERATED FRACTURE 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 | 2000-10-12 |
| Decision Date | 2001-02-21 |
| PMA | P900009 |
| Supplement | S012 |
| Product Code | LPQ |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track |
| 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