| Device | Therapy Cool Path Duo, Safire BLU Duo, Cool Path, Duo, Safire Duo, Therapy Cool Path Duo SP, Safire, BLU Duo SP and Ther |
| Generic Name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
| Applicant | St. Jude Medical, Inc. (Irvine Biomedical) |
| Date Received | 2021-01-13 |
| Decision Date | 2021-03-12 |
| PMA | P110016 |
| Supplement | S073 |
| Product Code | OAD |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |