Device Dossier
WATCHMAN FLX Pro - Cardiac occluder
Device Dossier for WATCHMAN FLX Pro - Cardiac occluder (Cardiac occluder, Class III, sponsor Boston Scientific). ARTG record, intended purpose, GMDN…
- GMDN category: Cardiac occluder
Intended purpose
Intended for percutaneous, transcatheter closure of the left atrial appendage.
Functional description
The WATCHMAN FLX Pro Device is a self-expanding nitinol structure with a porous membrane on the proximal face. The Closure Device is constrained within the Delivery System until deployment in the Left Atrial Appendage (LAA). The WATCHMAN FLX Pro Closure Device is permanently implanted at or slightly distal to the ostium (opening of the LAA) to trap potential emboli before they exit the LAA.