ARTG 400793Figulla Flex II ASD Occluder Procedure Pack - Cardiac occluder
ARTG ID: 400793 · Life Systems Medical Pty Ltd · Occlutech International AB · Class III · Started December 08, 2022
Good Name: Life Systems Medical Pty Ltd- Figulla Flex II ASD Occluder Procedure Pack - Cardiac occluder
- Risk Class
- Class III
- Product Type
- Procedure Pack
- ARTG Category
- General
- ARTG ID
- 400793
- Start Date
- December 08, 2022
- Effective Date
- December 08, 2022
- Country
- Sweden
- Address
- Landskronavagen 2, Helsingborg, SE - 25232
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.
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 registered under ARTG number 400793 and sponsored by Life Systems Medical Pty Ltd, manufactured by Occlutech International AB in Sweden. The device registration started on December 08, 2022.
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