NGV · System, Appendage Closure, Left Atrial
· Class 3
Overview
| Product Code | NGV |
|---|---|
| Device Name | System, Appendage Closure, Left Atrial |
| Device Class | Class 3 |
| Review Panel | |
| Implant | Yes |
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P130013S074 | WATCHMAN FLX Left Atrial Appendage (LAA) Closure Technology, WATCHMAN FLX Left Atrial Appendage Closure Device with Deli | Boston Scientific Corp | Jul 16, 2025 | APPR |
| P200049 | Amplatzer Amulet Left Atrial Appendage Occluder | ABBOTT MEDICAL | Aug 14, 2021 | APPR |
| P130013S035 | WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System and WATCHMAN Left Atrial Appendage Closure Device | Boston Scientific Corp | Jul 21, 2020 | APPR |
| P130013 | WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY | Boston Scientific Corp | Mar 13, 2015 | APPR |
Top Applicants
- Boston Scientific Corp — 3 clearances
- ABBOTT MEDICAL — 1 clearance
