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 NumberS054 Date Received09/29/2022 Decision Date10/28/2022 Product Code NGV Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No |
| Date Received | 2022-09-29 |
| Decision Date | 2022-10-28 |
| PMA | P130013 |
| Supplement | S054 |
| Product Code | NGV |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Boston Scientific Corp. one Scimed Place maple Grove, MN 55311-1566 PMA NumberP130013 Supplement NumberS054 Date Received09/29/2022 Decision Date10/28/2022 Product Code NGV Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No Combination ProductNo Approval Order Statement approval Of The Protocol For The Post-approval Study (PAS) Referenced Above. The PAS Protocol Has Been Submitted To Comply With The Conditions Of Approval Outlined In Our Approval Order For P130013/S043. |
| 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 |