ARTG 440630Impella 5.5 with SmartAssist Set - Intracardiac circulatory assist axial-pump catheter
ARTG ID: 440630 · Abiomed Australia Pty Ltd · Abiomed Inc · Class III · Started February 12, 2024
Good Name: Abiomed Australia Pty Ltd - Impella 5.5 with SmartAssist Set - Intracardiac circulatory assist axial-pump catheter
- Risk Class
- Class III
- Product Type
- Medical device system
- ARTG Category
- General
- ARTG ID
- 440630
- Start Date
- February 12, 2024
- Effective Date
- February 12, 2024
- Name
- Abiomed Inc
- Country
- United States of America
- Address
- 22 Cherry Hill Drive, DANVERS, MASSACHUSETTS, USA, 01923
The Set provides the Impella 5.5® with SmartAssist® heart pump and devices for inserting, placing and rinsing the pump. The Impella 5.5 with SmartAssist heart pump is an intracardiac pump for supporting the left ventricle. It is intended for clinical use in cardiology and cardiac surgery for up to 30 days for supporting the heart in patients with reduced left ventricular function.
Access comprehensive regulatory information for Impella 5.5 with SmartAssist Set - Intracardiac circulatory assist axial-pump catheter in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 440630 and sponsored by Abiomed Australia Pty Ltd, manufactured by Abiomed Inc in United States of America. The device registration started on February 12, 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.