Approval for revision of the indications and usage section of the labeling for models 1200, 1020-s, 1026, and 101, to include the definition of nonunion recommended by the orthopedic and rehabilitation devices panel on april 28, 1998 and required per fda's letter dated june 3, 1998 (i. E. , "nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing").
| 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 | 1998-06-24 |
| Decision Date | 1998-07-27 |
| PMA | P790002 |
| Supplement | S019 |
| Product Code | LOF |
| Advisory Committee | Orthopedic |
| Supplement Type | Real-time Process |
| 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