Australia TGA ARTG recordImpella CP with SmartAssist Set - Intracardiac circulatory assist axial-pump catheter
Australia TGA ARTG Registered Device · Abiomed Australia Pty Ltd · Abiomed Inc · Class III · Started November 26, 2021
Good Name: Abiomed Australia Pty Ltd - Impella CP with SmartAssist Set - Intracardiac circulatory assist axial-pump catheter
- Risk Class
- Class III
- Product Type
- Procedure Pack
- ARTG Category
- General
- Start Date
- November 26, 2021
- Effective Date
- November 26, 2021
- Name
- Abiomed Inc
- Country
- United States of America
- Address
- 22 Cherry Hill Drive, DANVERS, MASSACHUSETTS, USA, 01923
The Set provides the Impella CP® with SmartAssist heart pump and devices for inserting, placing and rinsing the pump. The Impella CP® with SmartAssist pump is a intracardiac pump for supporting the left ventricle; it is intended for clinical use in cardiology and in cardiac surgery for up to 5 days for supporting the native heart in patients with reduced left ventricular function.
Access comprehensive regulatory information for Impella CP 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 sponsored by Abiomed Australia Pty Ltd, manufactured by Abiomed Inc in United States of America. The device registration started on November 26, 2021.
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.