ARTG 483625EVOQUE Tricuspid Valve Replacement System - Tricuspid transcatheter heart valve bioprosthesis
ARTG ID: 483625 · Edwards Lifesciences Pty Ltd · Edwards Lifesciences LLC · Class III · Started March 21, 2025
Good Name: Edwards Lifesciences Pty Ltd - EVOQUE Tricuspid Valve Replacement System - Tricuspid transcatheter heart valve bioprosthesis
- Risk Class
- Class III
- Product Type
- Medical device system
- ARTG Category
- General
- ARTG ID
- 483625
- Start Date
- March 21, 2025
- Effective Date
- March 21, 2025
- Country
- United States of America
- Address
- One Edwards Way, Irvine, California, 92614
The EVOQUE tricuspid valve replacement system is indicated for the improvement of health status in patients with symptomatic severe tricuspid regurgitation despite being treated optimally with medical therapy for whom tricuspid valve replacement is deemed appropriate by a Heart Team.
Access comprehensive regulatory information for EVOQUE Tricuspid Valve Replacement System - Tricuspid transcatheter heart valve bioprosthesis in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 483625 and sponsored by Edwards Lifesciences Pty Ltd, manufactured by Edwards Lifesciences LLC in United States of America. The device registration started on March 21, 2025.
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.