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.
Software update to the automated test equipment (ate) that will set the value of open threshold and switch threshold for all proclaim, infinity, and proclaim drg devices to a constant value of 253 during manufacturing instead of calculating the trim value using a formula.
| 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 | 2017-06-02 |
| Decision Date | 2017-06-28 |
| PMA | P150004 |
| Supplement | S010 |
| Product Code | PMP |
| Advisory Committee | Neurology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |