This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the tacticath quartz catheter and tactisysquartz® equipment. This device is indicated for use in cardiacelectrophysiological mapping and for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used in conjunction with a compatible radiofrequency generator and three-dimensional mapping system.
| Device | TACTICATH QUARTZ SET |
| Classification Name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
| Generic Name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
| Applicant | St. Jude Medical |
| Date Received | 2013-11-29 |
| Decision Date | 2014-10-24 |
| Notice Date | 2014-11-21 |
| PMA | P130026 |
| Supplement | S |
| Product Code | OAE |
| Docket Number | 14M-1736 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | St. Jude Medical one St. Jude Medical Drive st. Paul, MN 55117 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P130026 | Original Filing | |
| S082 | 2022-11-16 | 30-day Notice |
| S081 | 2022-11-14 | 30-day Notice |
| S080 | 2022-09-30 | 30-day Notice |
| S079 | 2022-08-01 | 30-day Notice |
| S078 | 2022-01-27 | Real-time Process |
| S077 | ||
| S076 | 2021-09-14 | 30-day Notice |
| S075 | 2021-08-24 | 30-day Notice |
| S074 | 2021-05-26 | 30-day Notice |
| S073 | 2021-05-05 | 30-day Notice |
| S072 | ||
| S071 | 2021-04-19 | 30-day Notice |
| S070 | ||
| S069 | ||
| S068 | 2021-01-13 | Real-time Process |
| S067 | 2020-11-27 | 30-day Notice |
| S066 | ||
| S065 | 2020-09-18 | 30-day Notice |
| S064 | 2020-08-03 | 30-day Notice |
| S063 | ||
| S062 | ||
| S061 | 2020-05-06 | 30-day Notice |
| S060 | 2020-04-29 | 30-day Notice |
| S059 | 2020-03-19 | 30-day Notice |
| S058 | ||
| S057 | 2020-03-10 | 30-day Notice |
| S056 | 2020-03-10 | 30-day Notice |
| S055 | 2019-12-16 | 30-day Notice |
| S054 | 2019-11-20 | 30-day Notice |
| S053 | 2019-09-27 | Special (immediate Track) |
| S052 | 2019-09-26 | 30-day Notice |
| S051 | 2019-09-12 | Special (immediate Track) |
| S050 | 2019-08-20 | 30-day Notice |
| S049 | 2019-06-27 | Special (immediate Track) |
| S048 | ||
| S047 | 2019-05-22 | 30-day Notice |
| S046 | 2019-05-10 | Real-time Process |
| S045 | 2019-04-26 | 30-day Notice |
| S044 | 2019-03-25 | 30-day Notice |
| S043 | 2019-03-12 | Special (immediate Track) |
| S042 | 2019-02-14 | Normal 180 Day Track No User Fee |
| S041 | 2019-02-08 | 30-day Notice |
| S040 | 2019-02-08 | 30-day Notice |
| S039 | 2019-01-18 | Special (immediate Track) |
| S038 | 2019-01-15 | Normal 180 Day Track No User Fee |
| S037 | 2018-12-12 | Special (immediate Track) |
| S036 | 2018-09-27 | Normal 180 Day Track |
| S035 | 2018-07-05 | Special (immediate Track) |
| S034 | 2018-07-02 | Normal 180 Day Track |
| S033 | 2018-03-07 | 30-day Notice |
| S032 | 2018-02-21 | Real-time Process |
| S031 | 2018-02-12 | 30-day Notice |
| S030 | 2018-02-06 | 30-day Notice |
| S029 | 2018-02-05 | 30-day Notice |
| S028 | 2017-12-15 | 135 Review Track For 30-day Notice |
| S027 | 2017-10-31 | 30-day Notice |
| S026 | 2017-07-21 | Real-time Process |
| S025 | ||
| S024 | ||
| S023 | 2017-04-05 | 30-day Notice |
| S022 | 2016-08-12 | 30-day Notice |
| S021 | 2016-07-07 | 30-day Notice |
| S020 | 2016-05-11 | 30-day Notice |
| S019 | 2016-03-14 | 30-day Notice |
| S018 | 2016-03-07 | 30-day Notice |
| S017 | 2016-02-22 | Real-time Process |
| S016 | 2016-02-19 | 30-day Notice |
| S015 | 2016-01-21 | Special (immediate Track) |
| S014 | 2016-01-07 | 30-day Notice |
| S013 | 2015-12-07 | Special (immediate Track) |
| S012 | 2015-11-20 | Real-time Process |
| S011 | 2015-10-30 | Normal 180 Day Track No User Fee |
| S010 | 2015-09-23 | 30-day Notice |
| S009 | 2015-08-27 | Real-time Process |
| S008 | 2015-08-05 | Real-time Process |
| S007 | ||
| S006 | 2015-07-02 | Real-time Process |
| S005 | 2015-07-01 | Real-time Process |
| S004 | 2015-04-14 | Special (immediate Track) |
| S003 | 2015-03-27 | Real-time Process |
| S002 | 2015-02-27 | Special (immediate Track) |
| S001 | 2015-01-28 | 30-day Notice |