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.
Approval for a labeling change for the device to reference the results of an expanded patient data registry for patients treated with the device during the first two years of marketing for the approved indication.
| Device | ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR |
| Classification Name | Stimulator, Bone Growth, Non-invasive |
| Generic Name | Stimulator, Bone Growth, Non-invasive |
| Applicant | DJO, LLC |
| Date Received | 1996-02-20 |
| Decision Date | 1997-01-03 |
| PMA | P910066 |
| Supplement | S002 |
| 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 | DJO, LLC 1430 Decision Street vista, CA 92081-8553 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P910066 | Original Filing | |
| S031 | 2019-10-23 | Real-time Process |
| S030 | 2019-07-03 | 30-day Notice |
| S029 | 2018-05-23 | 30-day Notice |
| S028 | 2016-01-19 | Special (immediate Track) |
| S027 | 2015-06-24 | Special (immediate Track) |
| S026 | 2012-05-09 | Normal 180 Day Track No User Fee |
| S025 | 2008-06-12 | Normal 180 Day Track |
| S024 | 2007-10-12 | Real-time Process |
| S023 | 2007-02-05 | Real-time Process |
| S022 | 2006-08-31 | Normal 180 Day Track No User Fee |
| S021 | 2005-06-01 | Real-time Process |
| S020 | 2004-09-03 | Normal 180 Day Track No User Fee |
| S019 | 2004-01-20 | Normal 180 Day Track |
| S018 | ||
| S017 | 2002-12-20 | Normal 180 Day Track |
| S016 | 2001-04-11 | Real-time Process |
| S015 | 2000-03-31 | Real-time Process |
| S014 | 2000-02-15 | Real-time Process |
| S013 | 1999-02-22 | Real-time Process |
| S012 | 1998-09-22 | Real-time Process |
| S011 | 1998-08-20 | Panel Track |
| S010 | ||
| S009 | 1998-07-06 | Real-time Process |
| S008 | 1997-12-30 | Normal 180 Day Track |
| S007 | 1997-11-17 | Normal 180 Day Track |
| S006 | ||
| S005 | 1997-02-26 | Real-time Process |
| S004 | 1996-04-05 | Normal 180 Day Track |
| S003 | ||
| S002 | 1996-02-20 | Normal 180 Day Track |
| S001 |