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 System |
| Generic Name | System, Appendage Closure, Left Atrial |
| Applicant | Boston Scientific Corp.one Scimed Placemaple Grove, MN 55311-1566 PMA NumberP130013 Supplement NumberS047 Date Received04/07/2022 Decision Date05/06/2022 Product Code NGV Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-04-07 |
| Decision Date | 2022-05-06 |
| PMA | P130013 |
| Supplement | S047 |
| 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 NumberS047 Date Received04/07/2022 Decision Date05/06/2022 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 to Process Devices Using The Reduced EtO S756 Sterilization Cycle At The BSC Coventry Rhode Island, BSC Galway Ireland, And Steris Tullamore Ireland Facilities |
| 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 |