Changes to labeling including the addition of information regarding "treatment completion," (affects physician instruction manual), a description of the pma population and original and four year success rates (affects physician instruction and patient manuals) and the addition of a contraindication for pateints wearing impalntable defibrillators (affects physician instruction manual)
| Device | EBI BONE HEALING SYSTEM(R) |
| Classification Name | Stimulator, Bone Growth, Non-invasive |
| Generic Name | Stimulator, Bone Growth, Non-invasive |
| Applicant | EBI, LLC |
| Date Received | 1995-06-02 |
| Decision Date | 1996-04-09 |
| PMA | P790002 |
| Supplement | S016 |
| 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 | EBI, LLC 399 Jefferson Road parsippany, NJ 07054 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P790002 | | Original Filing |
| S038 |
2022-10-28 |
30-day Notice |
| S037 |
2018-03-01 |
30-day Notice |
| S036 |
2016-11-08 |
30-day Notice |
| S035 |
2016-02-11 |
30-day Notice |
| S034 |
2015-12-17 |
30-day Notice |
| S033 |
2015-10-08 |
30-day Notice |
| S032 |
2014-04-10 |
30-day Notice |
| S031 |
2014-02-07 |
Real-time Process |
| S030 |
2013-08-13 |
Special (immediate Track) |
| S029 |
2012-12-04 |
30-day Notice |
| S028 |
2012-05-16 |
Normal 180 Day Track |
| S027 |
2011-08-11 |
30-day Notice |
| S026 |
2010-06-29 |
Normal 180 Day Track |
| S025 |
2007-04-06 |
Real-time Process |
| S024 | | |
| S023 |
2005-06-17 |
Real-time Process |
| S022 |
2002-04-08 |
Normal 180 Day Track |
| S021 |
1999-11-30 |
Real-time Process |
| S020 |
1998-12-22 |
Real-time Process |
| S019 |
1998-06-24 |
Real-time Process |
| S018 |
1997-02-10 |
Normal 180 Day Track |
| S017 | | |
| S016 |
1995-06-02 |
Normal 180 Day Track |
| S015 |
1994-07-19 |
Normal 180 Day Track |
| S014 |
1992-09-28 |
Normal 180 Day Track |
| S013 |
1991-10-28 |
Normal 180 Day Track |
| S012 |
1989-08-07 |
Normal 180 Day Track |
| S011 |
1989-04-14 |
Normal 180 Day Track |
| S010 |
1989-03-02 |
Normal 180 Day Track |
| S009 |
1987-06-11 |
Normal 180 Day Track |
| S008 |
1986-10-16 |
Normal 180 Day Track |
| S007 | | |
| S006 |
1985-04-15 |
|
| S005 | | |
| S004 |
1983-03-02 |
|
| S003 |
1982-09-15 |
|
| S002 |
1982-07-15 |
|
| S001 |
1982-04-01 |
|
NIH GUDID Devices