Approval for the watchman laa closure technology. This device is indicated to reduce the risk of thromboembolism from the left atrial appendage (laa) in patients with non-valvular atrial fibrillation who: are at increased risk for stroke and systemic embolism based on chads2 or cha2ds2-vasc scores and are recommended for anticoagulation therapy; are deemed by their physicians to be suitable for warfarin; and have an appropriate rationale to seek a non-pharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device compared to warfarin.
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P130013 | | Original Filing |
| S056 |
2022-10-25 |
Real-time Process |
| S055 |
2022-10-18 |
30-day Notice |
| S054 |
2022-09-29 |
Normal 180 Day Track No User Fee |
| S053 | | |
| S052 | | |
| S051 |
2022-07-19 |
30-day Notice |
| S050 | | |
| S049 |
2022-06-22 |
30-day Notice |
| S048 |
2022-04-19 |
30-day Notice |
| S047 |
2022-04-07 |
30-day Notice |
| S046 |
2021-08-26 |
30-day Notice |
| S045 |
2021-07-30 |
30-day Notice |
| S044 |
2021-05-10 |
30-day Notice |
| S043 | | |
| S042 |
2021-03-03 |
Normal 180 Day Track No User Fee |
| S041 |
2021-01-11 |
Special (immediate Track) |
| S040 |
2020-12-03 |
30-day Notice |
| S039 |
2020-09-30 |
Real-time Process |
| S038 | | |
| S037 |
2020-03-12 |
30-day Notice |
| S036 |
2020-01-31 |
30-day Notice |
| S035 | | |
| S034 |
2019-11-12 |
30-day Notice |
| S033 |
2019-07-23 |
Real-time Process |
| S032 |
2019-06-25 |
30-day Notice |
| S031 | | |
| S030 |
2019-06-03 |
30-day Notice |
| S029 |
2019-05-17 |
30-day Notice |
| S028 |
2019-03-26 |
30-day Notice |
| S027 |
2019-02-01 |
30-day Notice |
| S026 |
2019-01-22 |
30-day Notice |
| S025 |
2018-12-07 |
Normal 180 Day Track No User Fee |
| S024 |
2018-11-16 |
30-day Notice |
| S023 |
2018-11-14 |
30-day Notice |
| S022 |
2018-11-05 |
30-day Notice |
| S021 | | |
| S020 |
2018-09-17 |
Real-time Process |
| S019 |
2018-02-21 |
Real-time Process |
| S018 |
2018-02-20 |
30-day Notice |
| S017 |
2017-12-15 |
Real-time Process |
| S016 |
2017-11-16 |
30-day Notice |
| S015 |
2017-08-30 |
30-day Notice |
| S014 |
2017-06-27 |
30-day Notice |
| S013 |
2017-03-17 |
30-day Notice |
| S012 |
2017-02-16 |
30-day Notice |
| S011 |
2016-11-15 |
30-day Notice |
| S010 |
2016-06-16 |
Real-time Process |
| S009 |
2016-05-19 |
Normal 180 Day Track No User Fee |
| S008 |
2016-04-05 |
Normal 180 Day Track No User Fee |
| S007 |
2016-04-05 |
30-day Notice |
| S006 |
2016-03-08 |
30-day Notice |
| S005 |
2015-08-21 |
Special (immediate Track) |
| S004 |
2015-08-12 |
Normal 180 Day Track No User Fee |
| S003 |
2015-08-07 |
30-day Notice |
| S002 |
2015-05-07 |
30-day Notice |
| S001 |
2015-04-10 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices