Device Dossier

WATCHMAN™ TruSeal™ Access System - Cardiac occluder delivery kit

Device Dossier for WATCHMAN™ TruSeal™ Access System - Cardiac occluder delivery kit (Cardiac occluder delivery kit, Class III, sponsor Boston…

Intended purpose

The WATCHMAN TruSeal Access System is intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.

Functional description

The WATCHMAN TruSeal Access System (Access Sheath and Dilator) is compatible with components of all WATCHMAN Left Atrial Appendage Closure Devices. The WATCHMAN TruSeal Access System is available in multiple curve shapes to assist with placement of the sheath into the Left Atrial Appendage for preparation of WATCHMAN LAA Closure Devices.

TGA Public Summary