Australia TGA ARTG recordMounted Bare CP Stent - Bare-metal aortic stent
Australia TGA ARTG Registered Device · Intervene Medical Pty Ltd · Numed Inc · Class III · Started August 07, 2018
Good Name: Intervene Medical Pty Ltd - Mounted CP Stent - Bare-metal aortic stent
- Risk Class
- Class III
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- August 07, 2018
- Effective Date
- May 09, 2019
- 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.
Access comprehensive regulatory information for Mounted Bare CP Stent - Bare-metal aortic stent 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.
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.