ARTG 283794Option ELITE Retrievable Vena Cava Filter System - Vena cava filter, optional
ARTG ID: 283794 · Life Healthcare Pty Ltd · Argon Medical Devices Inc · Class III · Started December 19, 2016
Good Name: Life Healthcare Pty Ltd - Option ELITE Retrievable Vena Cava Filter System - Vena cava filter, optional
- Risk Class
- Class III
- Product Type
- Medical device system
- ARTG Category
- General
- ARTG ID
- 283794
- Start Date
- December 19, 2016
- Effective Date
- December 19, 2016
- Country
- United States of America
- Address
- 1445 Flat Creek Road, Athens, Texas, 75751
Indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the inferior vena cava (IVC) in the following conditions: - Pulmonary thromboembolism when anticoagulants are contraindicated - Failure of anticoagulant therapy in thromboembolic disease - Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced - Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated The Filter may be removed according to supplied instructions in patients who no longer require a filter. Retrieval of the filter can only be performed by the jugular approach. The Angiographic Vessel Dilator is designed to provide angiographic visualization and linear measurement of the vasculature when used in conjunction with the delivery of radiopaque contrast media to the vena cava.
Access comprehensive regulatory information for Option ELITE Retrievable Vena Cava Filter System - Vena cava filter, optional in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 283794 and sponsored by Life Healthcare Pty Ltd, manufactured by Argon Medical Devices Inc in United States of America. The device registration started on December 19, 2016.
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