Australia flagARTG 459345

ELUVIA™ OVER-THE-WIRE Drug-Eluting Vascular Stent System - Peripheral artery stent, drug-eluting

ARTG ID: 459345 · Boston Scientific Pty Ltd · Boston Scientific Corporation · Class III · Started August 13, 2024

Good Name: Boston Scientific Pty Ltd - ELUVIA™ OVER-THE-WIRE Drug-Eluting Vascular Stent System - Peripheral artery stent, drug-eluting

Device classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration information
ARTG ID
459345
Start Date
August 13, 2024
Effective Date
August 13, 2024
Sponsor
Manufacturer
Country
United States of America
Address
300 Boston Scientific Way, Marlborough, MA, 01752
Intended purpose

The ELUVIA™ OVER-THE-WIRE Drug-Eluting Vascular Stent System is intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the native superficial femoral artery (SFA) and/or proximal popliteal artery with reference vessel diameters (RVD) ranging from 4.0 mm - 6.0 mm.

About this record

Access comprehensive regulatory information for ELUVIA™ OVER-THE-WIRE Drug-Eluting Vascular Stent 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 registered under ARTG number 459345 and sponsored by Boston Scientific Pty Ltd, manufactured by Boston Scientific Corporation in United States of America. The device registration started on August 13, 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.

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