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 updates to the warnings section of the instructions for use for ampere generator and its accessories.
| 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 | 2018-12-12 |
| Decision Date | 2019-01-10 |
| PMA | P130026 |
| Supplement | S037 |
| Product Code | OAE |
| Advisory Committee | Cardiovascular |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | St. Jude Medical one St. Jude Medical Drive st. Paul, MN 55117 |
| 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 |