Pure Global

Atherectomy peripheral angioplasty system

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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class IIb
Class IIb
Atherectomy peripheral angioplasty system
Australia TGA ARTG Registered Device
Good Name: Abbott Vascular Division of Abbott Medical Australia Pty Ltd - Atherectomy peripheral angioplasty system
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

โ€œThe 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.โ€

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
March 31, 2020
Effective Date
March 31, 2020
Manufacturer
Country
United States of America
Address
1225 Old Highway 8 NW, Saint Paul, MN, 55112