Approval to update the clinical data in the directions for use with the currently available data and make minor changes to the language in the directions for use and patient brochure
| Device | WATCHMAN Left Atrial Appendage Closure |
| Classification Name | System, Appendage Closure, Left Atrial |
| Generic Name | System, Appendage Closure, Left Atrial |
| Applicant | Boston Scientific Corp. |
| Date Received | 2019-07-23 |
| Decision Date | 2019-10-18 |
| PMA | P130013 |
| Supplement | S033 |
| Product Code | NGV |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Boston Scientific Corp. one Scimed Place maple Grove, MN 55311-1566 |
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