Product code NGV
- Device name
- System, Appendage Closure, Left Atrial
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- CV
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P130013S084 | WATCHMAN FLX™ Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLX™ Pro Left Atrial Appendage Closure | Boston Scientific Corp | 2026-05-18 |
| P130013S085 | WATCHMAN FLXTM Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLXTM Pro Left Atrial Appendage Closu | Boston Scientific Corp | 2026-04-23 |
| P130013S076 | WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY | Boston Scientific Corp | 2026-03-25 |
| P200049S017 | Amplatzer™ Amulet™ Left Atrial Appendage Occluder | ABBOTT MEDICAL | 2026-03-19 |
| P200049S016 | Amplatzer™ Amulet™ Left Atrial Appendage Occluder (Amulet) | ABBOTT MEDICAL | 2026-02-24 |
| P200049S015 | Amplatzer™ Amulet™ Left Atrial Appendage Occluder | ABBOTT MEDICAL | 2026-02-12 |
| P130013S083 | WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device with Delivery System | Boston Scientific Corp | 2026-02-12 |
| P200049S014 | Amplatzer™ Amulet™ Left Atrial Appendage Occluder | ABBOTT MEDICAL | 2025-12-23 |
| P130013S082 | WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System; WATCHMAN FLX Pro Left Atrial Appendage Cl | Boston Scientific Corp | 2025-12-18 |
| P130013S079 | WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device with Delivery System | Boston Scientific Corp | 2025-12-15 |
| P130013S078 | WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device with Delivery System | Boston Scientific Corp | 2025-12-15 |
| P130013S080 | WATCHMAN FLX™ Left Atrial Appendage (LAA) Closure Device with Delivery System; WATCHMAN FLX™ Pro Left Atrial Appendage ( | Boston Scientific Corp | 2025-12-12 |
| P130013S081 | WATCHMAN FLX Pro Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLX Left Atrial Appendage Closure D | Boston Scientific Corp | 2025-11-06 |
| P200049S013 | Amplatzer™ Amulet™ Left Atrial Appendage Occluder | ABBOTT MEDICAL | 2025-10-23 |
| P200049S012 | Amplatzer™ Amulet™ Left Atrial Appendage Occluder | ABBOTT MEDICAL | 2025-09-18 |
| P130013S077 | WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY | Boston Scientific Corp | 2025-09-04 |
| P130013S074 | WATCHMAN FLX Left Atrial Appendage (LAA) Closure Technology, WATCHMAN FLX Left Atrial Appendage Closure Device with Deli | Boston Scientific Corp | 2025-07-16 |
| P130013S075 | WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLX Pro Left Atrial Appendage Closure D | Boston Scientific Corp | 2025-05-05 |
| P130013S071 | WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Cl | Boston Scientific Corp | 2025-04-25 |
| P200049S009 | Amplatzer Amulet Left Atrial Appendage Occluder | ABBOTT MEDICAL | 2025-04-22 |
| P200049S011 | Amplatzer™ Amulet™ Left Atrial Appendage Occluder | ABBOTT MEDICAL | 2025-03-27 |
| P200049S010 | Amplatzer Amulet Left Atrial Appendage Occluder | ABBOTT MEDICAL | 2025-03-05 |
| P200049S008 | Amplatzer™ Amulet™ Left Atrial Appendage Occluder | ABBOTT MEDICAL | 2024-12-13 |
| P130013S072 | WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Cl | Boston Scientific Corp | 2024-11-01 |
| P200049S007 | Amplatzer™ Amulet™ Left Atrial Appendage Occluder | ABBOTT MEDICAL | 2024-10-01 |
| P130013S070 | WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Closure D | Boston Scientific Corp | 2024-09-23 |
| P200049S006 | Amplatzer Amulet Left Atrial Appendage Occluder | ABBOTT MEDICAL | 2024-06-26 |
| P130013S069 | WATCHMAN FLX Pro Left Atrial Appendage Closure (LAAC) Device with Delivery System | Boston Scientific Corp | 2024-06-14 |
| P130013S068 | WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System and WATCHMAN FLX Pro Left Atrial Appendage | Boston Scientific Corp | 2024-04-24 |
| P130013S067 | WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Cl | Boston Scientific Corp | 2024-04-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00191506040154 | WATCHMAN FLX™ Pro | BOSTON SCIENTIFIC CORPORATION | 2023-09-12 |
| 00191506040161 | WATCHMAN FLX™ Pro | BOSTON SCIENTIFIC CORPORATION | 2023-09-12 |
| 00191506040178 | WATCHMAN FLX™ Pro | BOSTON SCIENTIFIC CORPORATION | 2023-09-12 |
| 00191506040185 | WATCHMAN FLX™ Pro | BOSTON SCIENTIFIC CORPORATION | 2023-09-12 |
| 00191506040192 | WATCHMAN FLX™ Pro | BOSTON SCIENTIFIC CORPORATION | 2023-09-12 |
| 00191506004583 | WATCHMAN FLX™ Pro | BOSTON SCIENTIFIC CORPORATION | 2023-09-12 |
| 00191506004590 | WATCHMAN FLX™ Pro | BOSTON SCIENTIFIC CORPORATION | 2023-09-12 |
| 00191506004606 | WATCHMAN FLX™ Pro | BOSTON SCIENTIFIC CORPORATION | 2023-09-12 |
| 00191506004613 | WATCHMAN FLX™ Pro | BOSTON SCIENTIFIC CORPORATION | 2023-09-12 |
| 00191506004620 | WATCHMAN FLX™ Pro | BOSTON SCIENTIFIC CORPORATION | 2023-09-12 |
| 00191506004637 | WATCHMAN FLX™ Pro | BOSTON SCIENTIFIC CORPORATION | 2023-09-12 |
| 00191506040147 | WATCHMAN FLX™ Pro | BOSTON SCIENTIFIC CORPORATION | 2023-09-12 |
| 00811806013480 | Amplatzer™ Amulet™ | ST. JUDE MEDICAL, INC. | 2021-08-16 |
| 00811806013527 | Amplatzer™ Amulet™ | ST. JUDE MEDICAL, INC. | 2021-08-16 |
| 00811806013510 | Amplatzer™ Amulet™ | ST. JUDE MEDICAL, INC. | 2021-08-16 |
| 00811806013503 | Amplatzer™ Amulet™ | ST. JUDE MEDICAL, INC. | 2021-08-16 |
| 00811806013497 | Amplatzer™ Amulet™ | ST. JUDE MEDICAL, INC. | 2021-08-16 |
| 00811806013473 | Amplatzer™ Amulet™ | ST. JUDE MEDICAL, INC. | 2021-08-16 |
| 00811806013466 | Amplatzer™ Amulet™ | ST. JUDE MEDICAL, INC. | 2021-08-16 |
| 00811806013459 | Amplatzer™ Amulet™ | ST. JUDE MEDICAL, INC. | 2021-08-16 |
| 08714729860488 | WATCHMAN FLX™ | BOSTON SCIENTIFIC CORPORATION | 2020-07-28 |
| 08714729860495 | WATCHMAN FLX™ | BOSTON SCIENTIFIC CORPORATION | 2020-07-28 |
| 08714729860501 | WATCHMAN FLX™ | BOSTON SCIENTIFIC CORPORATION | 2020-07-28 |
| 08714729860518 | WATCHMAN FLX™ | BOSTON SCIENTIFIC CORPORATION | 2020-07-28 |
| 08714729860525 | WATCHMAN FLX™ | BOSTON SCIENTIFIC CORPORATION | 2020-07-28 |
| 08714729838227 | WATCHMAN® | BOSTON SCIENTIFIC CORPORATION | 2015-03-20 |
| 08714729838234 | WATCHMAN® | BOSTON SCIENTIFIC CORPORATION | 2015-03-20 |
| 08714729838241 | WATCHMAN® | BOSTON SCIENTIFIC CORPORATION | 2015-03-20 |
| 08714729838258 | WATCHMAN® | BOSTON SCIENTIFIC CORPORATION | 2015-03-20 |
| 08714729838265 | WATCHMAN® | BOSTON SCIENTIFIC CORPORATION | 2015-03-20 |