Approval for a manufacturing site located at boston scientific corporation, maple grove facility located at one scimed place, maple grove, minnesota, 55311 as an additional manufacturing site for the watchman closure device with delivery system.
| Device | WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) DEVICE |
| Classification Name | System, Appendage Closure, Left Atrial |
| Generic Name | System, Appendage Closure, Left Atrial |
| Applicant | Boston Scientific Corp. |
| Date Received | 2016-05-19 |
| Decision Date | 2016-08-04 |
| PMA | P130013 |
| Supplement | S009 |
| Product Code | NGV |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| 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