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.
Add an additional sterilization site for the flexability, sensor enabled (se) catheters.
| Device | 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 | 2017-04-28 |
| Decision Date | 2017-05-22 |
| PMA | P110016 |
| Supplement | S043 |
| Product Code | OAD |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |