Figulla Flex II ASD Occluder Procedure Pack - Cardiac occluder
Access comprehensive regulatory information for Figulla Flex II ASD Occluder Procedure Pack - Cardiac occluder in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Life Systems Medical Pty Ltd, manufactured by Occlutech International AB in Sweden. The device registration started on December 08, 2022.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.
A system including an occluder (Figulla Flex II ASD) and a pusher (Flex Pusher-II). The occluder is an implant for closure of an ASD II (Atrial Septum Defect of the Secundum Type) and is deployed using the pusher via a minimally invasive catheter delivery system. The system is intended for patients with substantiated Left-Right-Shunt and a clear indication for closure of the defect.