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Edwards Commander Delivery System - Valve-non-specific transcatheter heart valve bioprosthesis

ARTG ID: 475371 · Edwards Lifesciences Pty Ltd · Edwards Lifesciences LLC · Class III · Started January 08, 2025

Good Name: Edwards Lifesciences Pty Ltd - Edwards Commander Delivery System - Valve-non-specific transcatheter heart valve bioprosthesis

Device classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration information
ARTG ID
475371
Start Date
January 08, 2025
Effective Date
January 08, 2025
Sponsor
Manufacturer
Country
United States of America
Address
One Edwards Way, Irvine, California, 92614
Intended purpose

The delivery system and accessories are intended to facilitate the placement of the bioprosthesis via the transfemoral, transeptal, subclavian/axillary access approaches.

About this record

Access comprehensive regulatory information for Edwards Commander Delivery System - Valve-non-specific 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 475371 and sponsored by Edwards Lifesciences Pty Ltd, manufactured by Edwards Lifesciences LLC in United States of America. The device registration started on January 08, 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.

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