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 to modify the device labeling to include patient registry data in addition to the original data contained in the pma
| Device | PHYSIO STIM AND PHYSIO STIM LITE BONE GROWTH STIMULATORS |
| Classification Name | Stimulator, Bone Growth, Non-invasive |
| Generic Name | Stimulator, Bone Growth, Non-invasive |
| Applicant | Orthofix, Inc. |
| Date Received | 1997-08-25 |
| Decision Date | 2000-03-09 |
| PMA | P850007 |
| Supplement | S020 |
| 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 | Orthofix, Inc. 3451 Plano Parkway lewisville, TX 75056 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P850007 | Original Filing | |
| S046 | 2022-03-16 | Real-time Process |
| S045 | ||
| S044 | 2020-02-26 | 30-day Notice |
| S043 | 2019-09-16 | 30-day Notice |
| S042 | 2019-06-07 | 30-day Notice |
| S041 | 2019-04-15 | Real-time Process |
| S040 | 2018-09-27 | Real-time Process |
| S039 | 2018-05-24 | Real-time Process |
| S038 | 2017-12-07 | Real-time Process |
| S037 | 2017-08-15 | Normal 180 Day Track |
| S036 | 2017-03-24 | Real-time Process |
| S035 | 2016-07-05 | Normal 180 Day Track |
| S034 | 2015-07-28 | 30-day Notice |
| S033 | 2014-08-01 | 30-day Notice |
| S032 | 2011-10-03 | 30-day Notice |
| S031 | 2011-01-19 | Real-time Process |
| S030 | 2010-01-21 | Normal 180 Day Track No User Fee |
| S029 | 2009-08-04 | 30-day Notice |
| S028 | 2009-05-07 | Real-time Process |
| S027 | 2003-06-04 | Normal 180 Day Track |
| S026 | 2001-02-01 | Normal 180 Day Track |
| S025 | 2000-03-13 | Normal 180 Day Track |
| S024 | 1998-09-22 | Real-time Process |
| S023 | 1998-07-21 | Real-time Process |
| S022 | 1998-06-24 | Real-time Process |
| S021 | 1998-03-03 | Normal 180 Day Track |
| S020 | 1997-08-25 | Normal 180 Day Track |
| S019 | 1996-06-12 | Normal 180 Day Track |
| S018 | 1996-05-07 | Normal 180 Day Track |
| S017 | 1995-06-16 | Normal 180 Day Track |
| S016 | 1995-04-05 | Normal 180 Day Track |
| S015 | ||
| S014 | 1994-03-03 | Normal 180 Day Track |
| S013 | 1992-06-23 | Normal 180 Day Track |
| S012 | 1991-02-21 | Normal 180 Day Track |
| S011 | 1990-11-26 | Normal 180 Day Track |
| S010 | 1990-11-13 | Normal 180 Day Track |
| S009 | ||
| S008 | 1989-11-22 | Normal 180 Day Track |
| S007 | 1989-01-24 | Normal 180 Day Track |
| S006 | 1988-06-06 | Panel Track |
| S005 | 1988-01-28 | Normal 180 Day Track |
| S004 | 1987-08-05 | Normal 180 Day Track |
| S003 | 1987-06-17 | Normal 180 Day Track |
| S002 | 1986-12-10 | Normal 180 Day Track |
| S001 | 1986-06-30 | Normal 180 Day Track |