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Abiomed Inc

Manufacturer • United States of America · 28 devices on the TGA ARTG · 5 device classes · May 09, 2017 – Feb 12, 2024

28
Total Devices
5
Device Classes
2017
Earliest
2024
Latest
Recent device registrations
Latest 10 TGA ARTG device registrations
Impella 5.5 with SmartAssist Set - Intracardiac circulatory assist axial-pump catheter
Class IIIFeb 12, 2024
Sponsor: Abiomed Australia Pty Ltd
Impella 5.5 with SmartAssist Set - Intracardiac circulatory assist axial-pump catheter
ARTG 440630
Class IIIFeb 12, 2024
Sponsor: Abiomed Australia Pty Ltd
Surgical implant template, single-use
ARTG 389610
Class IIaJun 04, 2022
Sponsor: Abiomed Australia Pty Ltd
Surgical implant template, single-use
Class IIaJun 04, 2022
Sponsor: Abiomed Australia Pty Ltd
Impella 5.5 with SmartAssist - Intracardiac circulatory assist axial-pump catheter
ARTG 386932
Class IIIApr 11, 2022
Sponsor: Abiomed Australia Pty Ltd
Impella 5.5 with SmartAssist - Intracardiac circulatory assist axial-pump catheter
Class IIIApr 11, 2022
Sponsor: Abiomed Australia Pty Ltd
Catheter/tubing connection protector
Class IsFeb 04, 2022
Sponsor: Abiomed Australia Pty Ltd
Catheter/tubing connection protector
ARTG 383513
Class IsFeb 04, 2022
Sponsor: Abiomed Australia Pty Ltd
Impella CP with SmartAssist Set - Intracardiac circulatory assist axial-pump catheter
ARTG 379190
Class IIINov 26, 2021
Sponsor: Abiomed Australia Pty Ltd
Impella CP with SmartAssist Set - Intracardiac circulatory assist axial-pump catheter
Class IIINov 26, 2021
Sponsor: Abiomed Australia Pty Ltd
View All 28 Devices →
Risk class distribution
Devices by risk class
Class I
2
7.1% of total
Class IIa
6
21.4% of total
Class IIb
2
7.1% of total
Class III
12
42.9% of total
Class Is
6
21.4% of total
About this profile

Explore comprehensive manufacturer profile for Abiomed Inc through Pure Global AI's free Australia TGA ARTG medical device database. This company has manufactured 28 medical devices registered with TGA ARTG across 5 device classes. This manufacturer is based in United States of America. Their registration history spans from May 09, 2017 to Feb 12, 2024.

This page provides detailed insights including recent device registrations, risk class distribution (Class III: 12, Class Is: 6, Class IIa: 6, Class I: 2, Class IIb: 2), and complete regulatory information 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.

Free Manufacturer ProfilePowered by Pure Global AI28 Devices5 Device Classes