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:1) p140009/s037: mr conditional labeling, firmware version 1. 3, and clinician programmer and patient controller apps version 3. 7 (dbs mri mode, dbs shared frequency mode, dbs multistim programming, dbs monopolar survey mode, and minor software changes); and2) p010032/s141 and p150004/s20: firmware version 1. 3 and clinician programmer and patient controller apps version 3. 7 (minor software changes).
| Device | Proclaim Dorsal Root Ganglion (DRG) External Programmer Apps |
| Classification Name | Dorsal Root Ganglion Stimulator For Pain Relief |
| Generic Name | Dorsal Root Ganglion Stimulator For Pain Relief |
| Applicant | Abbott Medical |
| Date Received | 2018-02-13 |
| Decision Date | 2018-07-19 |
| PMA | P150004 |
| Supplement | S020 |
| Product Code | PMP |
| Advisory Committee | Neurology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |