Covered Mounted CP Stent - General aorta endovascular stent-graft - ARTG 307883
Access comprehensive regulatory information for Covered Mounted CP Stent - General aorta endovascular stent-graft in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 307883 and sponsored by Intervene Medical Pty Ltd, manufactured by Numed Inc in United States of America. The device registration started on August 07, 2018.
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.
For implantation in the native and/or recurrent coarctation of the aorta on patients with: • Stenosis of the aorta resulting in significant anatomic narrowing as determined by angiography or non-invasive imaging; • Stenosis of the aorta resulting in hemodynamic alterations, resulting in systolic pressure gradient, systemic hypertension or altered left ventricular function; • Stenosis of the aorta where balloon angioplasty is ineffective or contraindicated; • Stenosis diameter <20% of the adjacent vessel diameter. Stenosis that would present increased risk of vascular damage of disruption; or aneurysm associated with Coarctation of the aorta. Right Ventricular Outflow Tract (RVOT) Indicated for treatment of right ventricle to pulmonary artery (right ventricular outflow tract) conduit disruptions that are identified during conduit pre-dilatation procedures performed in preparation for transcatheter pulmonary valve replacement.