Australia TGA ARTG recordLutonix™ 035 Drug Coated PTA Balloon - Peripheral angioplasty balloon catheter, drug-eluting
Australia TGA ARTG Registered Device · Bard Australia Pty Ltd · Bard Peripheral Vascular Inc · Class III · Started March 28, 2024
Good Name: Bard Australia Pty Ltd - Lutonix™ 035 Drug Coated PTA Balloon - Peripheral angioplasty balloon catheter, drug-eluting
- Risk Class
- Class III
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- March 28, 2024
- Effective Date
- March 28, 2024
- Country
- United States of America
- Address
- 1625 West 3rd Street, Tempe, AZ, 85281
Lutonix™ 035 Drug Coated Balloon Catheter is intended for Percutaneous Transluminal Angioplasty (PTA) and to deliver antiproliferative drug to the vessel wall. The Lutonix™ 035 Drug Coated Balloon Catheter is indicated for the treatment of stenotic or occlusive lesions in the femoropopliteal arteries, including in-stent restenosis, in patients with peripheral arterial disease and in dysfunctional native arteriovenous fistula or synthetic arteriovenous grafts.
Access comprehensive regulatory information for Lutonix™ 035 Drug Coated PTA Balloon - Peripheral angioplasty balloon catheter, drug-eluting in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Bard Australia Pty Ltd, manufactured by Bard Peripheral Vascular Inc in United States of America. The device registration started on March 28, 2024.
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.