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 the labeling to be in conformance with iec 60601-1-6 ed. 3. 1, iec 60601-1-2, ansi/aami es 60601-1:2005/a1:2012 and iec 60601-11:2011.
| Device | OL1000, OL1000 SC AND SPINALOGIC BONE GROWTH STIMULATORS |
| Classification Name | Stimulator, Bone Growth, Non-invasive |
| Generic Name | Stimulator, Bone Growth, Non-invasive |
| Applicant | DJO, LLC |
| Date Received | 2016-01-19 |
| Decision Date | 2016-02-18 |
| PMA | P910066 |
| Supplement | S028 |
| Product Code | LOF |
| Advisory Committee | Orthopedic |
| Supplement Type | Special (immediate 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 |