Approval of changes being effected (cbe) for the enhancement and harmonization of the physician and patient labeling to include precaution statements regarding risks of loss of coordination during activities requiring coordination (e. G. Swimming) and bathing in the labeling across the device type, as requested in the fda labeling change request letter dated june 12, 2020 and updated label change request via email on june 25, 2020.
| Device | Infinity Deep Brain Stimulation (DBS) System |
| Generic Name | Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
| Applicant | Abbott Medical |
| Date Received | 2020-07-13 |
| Decision Date | 2020-08-12 |
| PMA | P140009 |
| Supplement | S061 |
| Advisory Committee | Neurology |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Abbott Medical 6901 Prestion Road plano, TX 75024 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P140009 | | Original Filing |
| S080 |
2022-09-29 |
30-day Notice |
| S079 |
2022-09-21 |
30-day Notice |
| S078 |
2022-06-02 |
30-day Notice |
| S077 | | |
| S076 |
2022-02-22 |
30-day Notice |
| S075 |
2022-01-18 |
30-day Notice |
| S074 |
2021-10-22 |
Real-time Process |
| S073 | | |
| S072 |
2021-07-01 |
30-day Notice |
| S071 | | |
| S070 |
2021-06-15 |
Special (immediate Track) |
| S069 |
2021-05-10 |
30-day Notice |
| S068 |
2021-03-25 |
30-day Notice |
| S067 | | |
| S066 |
2021-02-08 |
30-day Notice |
| S065 |
2020-10-28 |
135 Review Track For 30-day Notice |
| S064 |
2020-09-09 |
Normal 180 Day Track |
| S063 |
2020-07-27 |
Real-time Process |
| S062 | | |
| S061 |
2020-07-13 |
Special (immediate Track) |
| S060 |
2020-05-07 |
30-day Notice |
| S059 |
2020-04-30 |
30-day Notice |
| S058 | | |
| S057 |
2020-04-06 |
30-day Notice |
| S056 |
2020-04-06 |
30-day Notice |
| S055 |
2020-02-03 |
30-day Notice |
| S054 |
2019-12-13 |
30-day Notice |
| S053 | | |
| S052 | | |
| S051 |
2019-10-21 |
30-day Notice |
| S050 |
2019-08-09 |
Special (immediate Track) |
| S049 | | |
| S048 |
2019-07-01 |
30-day Notice |
| S047 |
2019-05-07 |
Normal 180 Day Track No User Fee |
| S046 | | |
| S045 |
2019-02-01 |
30-day Notice |
| S044 |
2018-12-17 |
30-day Notice |
| S043 |
2018-11-08 |
30-day Notice |
| S042 |
2018-10-19 |
30-day Notice |
| S041 |
2018-10-18 |
Special (immediate Track) |
| S040 |
2018-09-06 |
30-day Notice |
| S039 | | |
| S038 |
2018-05-04 |
135 Review Track For 30-day Notice |
| S037 |
2018-02-13 |
Normal 180 Day Track |
| S036 |
2018-02-02 |
135 Review Track For 30-day Notice |
| S035 |
2017-12-18 |
30-day Notice |
| S034 |
2017-12-15 |
Real-time Process |
| S033 |
2017-12-15 |
30-day Notice |
| S032 |
2017-11-16 |
30-day Notice |
| S031 |
2017-11-13 |
30-day Notice |
| S030 |
2017-09-11 |
Real-time Process |
| S029 |
2017-09-08 |
30-day Notice |
| S028 |
2017-08-10 |
30-day Notice |
| S027 |
2017-07-28 |
Normal 180 Day Track No User Fee |
| S026 | | |
| S025 |
2017-06-26 |
30-day Notice |
| S024 |
2017-06-02 |
30-day Notice |
| S023 |
2017-02-14 |
Real-time Process |
| S022 |
2016-11-07 |
Normal 180 Day Track |
| S021 |
2016-11-01 |
30-day Notice |
| S020 |
2016-10-11 |
Real-time Process |
| S019 |
2016-07-11 |
Real-time Process |
| S018 | | |
| S017 |
2016-06-22 |
Real-time Process |
| S016 |
2016-06-13 |
30-day Notice |
| S015 |
2016-06-06 |
Normal 180 Day Track |
| S014 |
2016-04-28 |
30-day Notice |
| S013 |
2016-03-21 |
30-day Notice |
| S012 |
2016-02-02 |
30-day Notice |
| S011 |
2016-01-27 |
30-day Notice |
| S010 |
2015-12-11 |
Normal 180 Day Track |
| S009 |
2015-11-09 |
30-day Notice |
| S008 |
2015-11-06 |
30-day Notice |
| S007 |
2015-10-08 |
30-day Notice |
| S006 |
2015-10-07 |
30-day Notice |
| S005 |
2015-09-21 |
Real-time Process |
| S004 |
2015-08-21 |
Normal 180 Day Track No User Fee |
| S003 |
2015-08-14 |
30-day Notice |
| S002 |
2015-08-04 |
Real-time Process |
| S001 |
2015-07-02 |
Normal 180 Day Track |
NIH GUDID Devices