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 axium neurostimulator system. The axium neurostimulator system is indicated for spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable* pain of the lower limbs in adult patients with complex regional pain syndrome (crps) types i and ii*.
| Device | Axium Neurostimulator System |
| Classification Name | Dorsal Root Ganglion Stimulator For Pain Relief |
| Generic Name | Dorsal Root Ganglion Stimulator For Pain Relief |
| Applicant | Abbott Medical |
| Date Received | 2018-05-30 |
| Decision Date | 2019-03-26 |
| PMA | P150004 |
| Supplement | S023 |
| Product Code | PMP |
| Advisory Committee | Neurology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Ode/oir |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Abbott Medical 6901 Preston Road plano, TX 75024 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P150004 | Original Filing | |
| S057 | 2022-05-23 | Real-time Process |
| S056 | 2022-02-22 | 30-day Notice |
| S055 | 2022-01-18 | 30-day Notice |
| S054 | 2021-10-22 | Real-time Process |
| S053 | ||
| S052 | ||
| S051 | 2021-07-07 | Normal 180 Day Track No User Fee |
| S050 | 2021-07-01 | 30-day Notice |
| S049 | ||
| S048 | 2021-06-15 | Special (immediate Track) |
| S047 | 2021-05-10 | 30-day Notice |
| S046 | 2021-03-25 | 30-day Notice |
| S045 | ||
| S044 | ||
| S043 | 2020-09-09 | Normal 180 Day Track |
| S042 | 2020-07-27 | Real-time Process |
| S041 | ||
| S040 | ||
| S039 | 2020-05-07 | 30-day Notice |
| S038 | 2020-04-30 | 30-day Notice |
| S037 | ||
| S036 | 2020-04-06 | 30-day Notice |
| S035 | 2020-04-06 | 30-day Notice |
| S034 | 2019-12-13 | 30-day Notice |
| S033 | ||
| S032 | 2019-10-21 | 30-day Notice |
| S031 | 2019-07-01 | 30-day Notice |
| S030 | 2019-05-02 | Real-time Process |
| S029 | ||
| S028 | 2018-11-08 | 30-day Notice |
| S027 | 2018-09-28 | Real-time Process |
| S026 | 2018-09-04 | Real-time Process |
| S025 | 2018-08-20 | 30-day Notice |
| S024 | 2018-06-18 | Real-time Process |
| S023 | 2018-05-30 | Normal 180 Day Track No User Fee |
| S022 | 2018-04-20 | 30-day Notice |
| S021 | ||
| S020 | 2018-02-13 | Normal 180 Day Track |
| S019 | 2017-12-18 | 30-day Notice |
| S018 | 2017-11-16 | 30-day Notice |
| S017 | 2017-11-15 | 30-day Notice |
| S016 | 2017-11-09 | 30-day Notice |
| S015 | 2017-09-13 | 30-day Notice |
| S014 | 2017-09-11 | Real-time Process |
| S013 | 2017-08-22 | 30-day Notice |
| S012 | 2017-08-10 | 30-day Notice |
| S011 | ||
| S010 | 2017-06-02 | 30-day Notice |
| S009 | 2017-04-06 | 30-day Notice |
| S008 | 2017-04-03 | Normal 180 Day Track |
| S007 | 2017-02-14 | Normal 180 Day Track No User Fee |
| S006 | 2016-11-07 | Normal 180 Day Track |
| S005 | 2016-10-05 | Normal 180 Day Track No User Fee |
| S004 | 2016-07-21 | 30-day Notice |
| S003 | ||
| S002 | 2016-06-06 | Normal 180 Day Track |
| S001 | 2016-03-11 | Normal 180 Day Track No User Fee |