Australia TGA ARTG recordAtherectomy peripheral angioplasty system
Australia TGA ARTG Registered Device · Abbott Vascular Division of Abbott Medical Australia Pty Ltd · Cardiovascular Systems Inc · Class IIb · Started March 31, 2020
Good Name: Abbott Vascular Division of Abbott Medical Australia Pty Ltd - Atherectomy peripheral angioplasty system
- Risk Class
- Class IIb
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- March 31, 2020
- Effective Date
- March 31, 2020
- Country
- United States of America
- Address
- 1225 Old Highway 8 NW, Saint Paul, MN, 55112
“The STEALTH 360 Peripheral Orbital Atherectomy Device is, part of a percutaneous orbital atherectomy system, indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and are acceptable candidates for percutaneous transluminal atherectomy.”
Access comprehensive regulatory information for Atherectomy peripheral angioplasty system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Abbott Vascular Division of Abbott Medical Australia Pty Ltd, manufactured by Cardiovascular Systems Inc in United States of America. The device registration started on March 31, 2020.
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.