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.
| Device | WATCHMAN FLX™ Left Atrial Appendage Closure with Delivery System |
| Generic Name | System, Appendage Closure, Left Atrial |
| Applicant | Boston Scientific Corp.one Scimed Placemaple Grove, MN 55311-1566 PMA NumberP130013 Supplement NumberS048 Date Received04/19/2022 Decision Date05/19/2022 Product Code NGV Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-04-19 |
| Decision Date | 2022-05-19 |
| PMA | P130013 |
| Supplement | S048 |
| Product Code | NGV |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Boston Scientific Corp. one Scimed Place maple Grove, MN 55311-1566 PMA NumberP130013 Supplement NumberS048 Date Received04/19/2022 Decision Date05/19/2022 Product Code NGV Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement approval To Add An Alternate Wetline Process Used The In Manufacturing Of The WATCHMAN FLX Implant |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 08714729838210 | P130013 | 000 |
| 08714729838227 | P130013 | 000 |
| 08714729838234 | P130013 | 000 |
| 08714729838241 | P130013 | 000 |
| 08714729838258 | P130013 | 000 |
| 08714729838265 | P130013 | 000 |
| 08714729838197 | P130013 | 000 |
| 08714729838203 | P130013 | 000 |
| 08714729860488 | P130013 | 035 |
| 08714729860495 | P130013 | 035 |
| 08714729860501 | P130013 | 035 |
| 08714729860518 | P130013 | 035 |
| 08714729860525 | P130013 | 035 |
| 00191506004637 | P130013 | 057 |
| 00191506004620 | P130013 | 057 |
| 00191506004613 | P130013 | 057 |
| 00191506004606 | P130013 | 057 |
| 00191506004590 | P130013 | 057 |
| 00191506004583 | P130013 | 057 |