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 | SPF-4 IMPLANTABLE BONE GROWTH STIMULATOR |
| Classification Name | Stimulator, Invasive Bone Growth |
| Generic Name | Stimulator, Invasive Bone Growth |
| Applicant | EBI, LLC |
| Date Received | 1988-10-12 |
| Decision Date | 1988-10-28 |
| PMA | P850035 |
| Supplement | S006 |
| Product Code | LOE |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | EBI, LLC 399 Jefferson Road parsippany, NJ 07054 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P850035 | Original Filing | |
| S058 | 2022-10-28 | 30-day Notice |
| S057 | 2022-05-27 | Real-time Process |
| S056 | 2021-01-21 | 30-day Notice |
| S055 | 2019-06-21 | 30-day Notice |
| S054 | ||
| S053 | 2018-04-09 | 30-day Notice |
| S052 | 2018-04-04 | 30-day Notice |
| S051 | 2018-04-02 | 135 Review Track For 30-day Notice |
| S050 | 2018-03-29 | 30-day Notice |
| S049 | 2018-03-09 | 30-day Notice |
| S048 | 2018-03-01 | 30-day Notice |
| S047 | 2018-02-21 | 30-day Notice |
| S046 | 2018-02-13 | 30-day Notice |
| S045 | 2017-05-04 | 30-day Notice |
| S044 | 2017-03-14 | 30-day Notice |
| S043 | 2016-10-31 | Special (immediate Track) |
| S042 | 2016-02-19 | Special (immediate Track) |
| S041 | 2015-12-17 | 30-day Notice |
| S040 | 2015-11-19 | 30-day Notice |
| S039 | 2015-10-08 | 30-day Notice |
| S038 | 2014-08-20 | 30-day Notice |
| S037 | ||
| S036 | 2013-09-06 | 30-day Notice |
| S035 | 2013-04-30 | 30-day Notice |
| S034 | 2012-02-01 | 30-day Notice |
| S033 | 2008-07-22 | Normal 180 Day Track No User Fee |
| S032 | 2008-07-17 | 30-day Notice |
| S031 | 2007-02-23 | Real-time Process |
| S030 | 2004-06-09 | Normal 180 Day Track |
| S029 | 2002-06-13 | Normal 180 Day Track |
| S028 | 2000-05-30 | Real-time Process |
| S027 | ||
| S026 | ||
| S025 | 2000-03-31 | Normal 180 Day Track |
| S024 | 1998-07-06 | Normal 180 Day Track |
| S023 | 1998-04-09 | Real-time Process |
| S022 | 1997-04-08 | Real-time Process |
| S021 | 1996-10-17 | Normal 180 Day Track |
| S020 | 1996-07-19 | Normal 180 Day Track |
| S019 | 1996-03-13 | Normal 180 Day Track |
| S018 | 1995-12-08 | Special (immediate Track) |
| S017 | 1994-11-22 | Normal 180 Day Track |
| S016 | 1994-11-15 | Normal 180 Day Track |
| S015 | ||
| S014 | ||
| S013 | 1992-03-27 | Normal 180 Day Track |
| S012 | 1991-05-10 | Normal 180 Day Track |
| S011 | ||
| S010 | 1990-10-25 | Normal 180 Day Track |
| S009 | ||
| S008 | 1990-05-31 | Normal 180 Day Track |
| S007 | 1988-12-16 | Normal 180 Day Track |
| S006 | 1988-10-12 | Normal 180 Day Track |
| S005 | 1988-04-18 | Normal 180 Day Track |
| S004 | 1988-03-16 | Normal 180 Day Track |
| S003 | 1988-02-26 | Normal 180 Day Track |
| S002 | 1988-01-15 | Normal 180 Day Track |
| S001 |
| Device ID | PMA | Supp |
|---|---|---|
| 00812301020096 | P850035 | 032 |
| 00812301020089 | P850035 | 032 |
| 00812301020133 | P850035 | 033 |
| 00812301020126 | P850035 | 033 |