Approval for two design and component changes: 1) changes to exogen 2000+ printed circuit board to implement corrective action for field failure and returns. This corrective action involves two design changes: i) replace 2 diodes on te printed circuit board with light emitting diodes. Ii) add a 1000 pf capacitor to reduce electrical noise. 2) replace both exogen 2000+ and exogen 3000 transducer cables with a more cost effective model.
| Device | EXOGEN 2000+ AND EXOGEN 3000 |
| 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 | 2004-01-29 |
| Decision Date | 2004-03-12 |
| PMA | P900009 |
| Supplement | S018 |
| Product Code | LPQ |
| Advisory Committee | Orthopedic |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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