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.
Addition of a warning statement to the instructions for use regarding atrioesophageal fistulas
| Device | FlexAbility Ablation Catheter and FlexAbility Ablation Catheter, Sensor Enabled |
| Classification Name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
| Generic Name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
| Applicant | St. Jude Medical, Inc. (Irvine Biomedical) |
| Date Received | 2019-09-12 |
| Decision Date | 2019-10-09 |
| PMA | P110016 |
| Supplement | S064 |
| Product Code | OAD |
| 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, Inc. (Irvine Biomedical) 2375 Morse Avenue irvine, CA 92614-6233 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P110016 | Original Filing | |
| S081 | 2022-11-14 | 30-day Notice |
| S080 | ||
| S079 | 2021-09-14 | 30-day Notice |
| S078 | 2021-08-24 | 30-day Notice |
| S077 | 2021-05-26 | 30-day Notice |
| S076 | 2021-04-19 | 30-day Notice |
| S075 | 2021-04-13 | 30-day Notice |
| S074 | 2021-02-25 | 30-day Notice |
| S073 | 2021-01-13 | Real-time Process |
| S072 | 2020-10-28 | Real-time Process |
| S071 | 2020-09-18 | 30-day Notice |
| S070 | ||
| S069 | 2020-05-06 | 30-day Notice |
| S068 | 2020-03-19 | 30-day Notice |
| S067 | ||
| S066 | 2020-02-04 | 30-day Notice |
| S065 | 2019-09-26 | 30-day Notice |
| S064 | 2019-09-12 | Special (immediate Track) |
| S063 | 2019-06-24 | Normal 180 Day Track No User Fee |
| S062 | 2019-04-26 | 30-day Notice |
| S061 | 2019-03-25 | 30-day Notice |
| S060 | 2019-03-15 | 30-day Notice |
| S059 | 2019-02-14 | Normal 180 Day Track No User Fee |
| S058 | 2018-12-12 | Special (immediate Track) |
| S057 | 2018-05-18 | Special (immediate Track) |
| S056 | 2018-03-27 | 30-day Notice |
| S055 | 2018-02-14 | 30-day Notice |
| S054 | 2018-02-12 | 30-day Notice |
| S053 | 2018-02-05 | 30-day Notice |
| S052 | 2017-11-28 | 30-day Notice |
| S051 | 2017-11-02 | 30-day Notice |
| S050 | 2017-10-27 | 135 Review Track For 30-day Notice |
| S049 | 2017-08-22 | 30-day Notice |
| S048 | ||
| S047 | 2017-06-30 | 30-day Notice |
| S046 | 2017-05-04 | 30-day Notice |
| S045 | 2017-04-28 | 30-day Notice |
| S044 | 2017-05-01 | 30-day Notice |
| S043 | 2017-04-28 | 30-day Notice |
| S042 | ||
| S041 | 2017-03-28 | 30-day Notice |
| S040 | 2017-03-20 | 30-day Notice |
| S039 | 2017-03-13 | 30-day Notice |
| S038 | 2017-03-03 | 30-day Notice |
| S037 | ||
| S036 | 2016-09-08 | Special (immediate Track) |
| S035 | 2016-08-12 | 30-day Notice |
| S034 | 2016-06-24 | 135 Review Track For 30-day Notice |
| S033 | 2016-05-27 | 30-day Notice |
| S032 | 2016-05-27 | 30-day Notice |
| S031 | 2016-03-17 | 30-day Notice |
| S030 | 2016-03-14 | 30-day Notice |
| S029 | 2016-02-19 | 30-day Notice |
| S028 | 2015-11-25 | 30-day Notice |
| S027 | 2015-11-20 | Real-time Process |
| S026 | 2015-11-12 | Special (immediate Track) |
| S025 | 2015-11-05 | Normal 180 Day Track |
| S024 | 2015-10-30 | Normal 180 Day Track No User Fee |
| S023 | 2015-09-23 | 30-day Notice |
| S022 | 2015-09-01 | 30-day Notice |
| S021 | 2015-08-21 | Normal 180 Day Track No User Fee |
| S020 | 2015-08-20 | 30-day Notice |
| S019 | ||
| S018 | 2015-06-29 | Special (immediate Track) |
| S017 | 2015-04-20 | 30-day Notice |
| S016 | 2015-02-05 | Normal 180 Day Track No User Fee |
| S015 | 2015-02-04 | Special (immediate Track) |
| S014 | 2014-11-07 | Real-time Process |
| S013 | 2014-06-19 | Normal 180 Day Track |
| S012 | 2014-04-30 | Normal 180 Day Track No User Fee |
| S011 | 2014-03-03 | Real-time Process |
| S010 | 2013-11-27 | Normal 180 Day Track |
| S009 | 2013-08-30 | 30-day Notice |
| S008 | 2013-04-01 | Panel Track |
| S007 | 2013-03-07 | Normal 180 Day Track |
| S006 | 2013-01-24 | Real-time Process |
| S005 | 2012-07-11 | 135 Review Track For 30-day Notice |
| S004 | 2012-07-10 | Real-time Process |
| S003 | 2012-06-25 | Normal 180 Day Track |
| S002 | 2012-05-11 | Real-time Process |
| S001 | 2012-03-29 | 135 Review Track For 30-day Notice |