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Zilver PTX Drug-Eluting Peripheral Stent with the Thumbwheel Delivery System - Peripheral artery stent, drug-eluting

Access comprehensive regulatory information for Zilver PTX Drug-Eluting Peripheral Stent with the Thumbwheel Delivery System - Peripheral artery stent, drug-eluting in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by William A Cook Australia Pty Ltd, manufactured by Cook Ireland Ltd in Ireland. The device registration started on August 24, 2016.

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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TGA ARTG Official Data
Class III
Class III
Zilver PTX Drug-Eluting Peripheral Stent with the Thumbwheel Delivery System - Peripheral artery stent, drug-eluting
Australia TGA ARTG Registered Device
Good Name: William A Cook Australia Pty Ltd - Zilver PTX Drug-Eluting Peripheral Stent with the Thumbwheel Delivery System - Peripheral artery stent, drug-eluting
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Intended Purpose

The Zilver PTX Drug-Eluting Peripheral Stent is intended to improve luminal patency by imparting an outward radial force on the inner wall of the above-the-knee femoropopliteal arteries.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
August 24, 2016
Effective Date
November 29, 2023
Manufacturer
Country
Ireland
Address
O'Halloran Road National Technology Park, Limerick