Australia TGA ARTG recordCovered Mounted CP Stent - General aorta endovascular stent-graft
Australia TGA ARTG Registered Device · Intervene Medical Pty Ltd · Numed Inc · Class III · Started August 07, 2018
Good Name: Intervene Medical Pty Ltd - Covered Mounted CP Stent - General aorta endovascular stent-graft
- Risk Class
- Class III
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- August 07, 2018
- Effective Date
- February 15, 2021
- Name
- Numed Inc
- Country
- United States of America
- Address
- 2880 Main Street, HOPKINTON , New York, 12965
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.
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 sponsored by Intervene Medical Pty Ltd, manufactured by Numed Inc in United States of America. The device registration started on August 07, 2018.
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