This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | BIO OSTEOGEN SYSTEM 204 |
| Classification Name | Stimulator, Bone Growth, Non-invasive |
| Generic Name | Stimulator, Bone Growth, Non-invasive |
| Applicant | EBI, LLC |
| Date Received | 1982-07-15 |
| Decision Date | 1982-08-20 |
| PMA | P790002 |
| Supplement | S002 |
| Product Code | LOF |
| Advisory Committee | Orthopedic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | EBI, LLC 399 Jefferson Road parsippany, NJ 07054 |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00812301020492 | P790002 | 026 |
| 00812301020508 | P790002 | 026 |
| 00812301020515 | P790002 | 026 |
| 00812301020522 | P790002 | 026 |
| 00812301020539 | P790002 | 026 |
| 00812301020546 | P790002 | 026 |
| 00812301020577 | P790002 | 026 |
| 00812301020584 | P790002 | 026 |
| 00812301020591 | P790002 | 026 |
| 00812301020607 | P790002 | 026 |
| 00812301020645 | P790002 | 026 |
| 00812301020638 | P790002 | 026 |
| 00812301020621 | P790002 | 026 |
| 00812301020614 | P790002 | 026 |
| 00812301020478 | P790002 | 028 |
| 00812301020461 | P790002 | 028 |
| 00812301020454 | P790002 | 028 |
| 00812301020447 | P790002 | 028 |
| 00812301020676 | P790002 | 028 |
| 00812301020485 | P790002 | 028 |
| 00812301020553 | P790002 | 028 |
| 00812301020560 | P790002 | 028 |
| 00812301020652 | P790002 | 028 |
| 00812301020669 | P790002 | 028 |
| 00812301020430 | P790002 | 028 |