tga application

This is the Registration of the 4G VentrAssist (LVAS) it is a System not a device, the TGA have classified it as a LVAS 4G which is in trials, this is the Commerically Ready Grant 4G Ventrassist (Tets Technology) waiting for approval, after all the Australian Government gave them nearly 3 Million to get this up and running and another arm of the Government the TGA is processing it.

https://www.tgasime.health.gov.au/SIME/ARTG/ARTGPublicWeb.nsf/DEVpublic?SearchView&Query=VentrAssist%204G&start=1&searchOrder=4&searchMax=1000&searchWV=1&searchFuzzy=1

This is the 3G model in Trials at present, this is a LVAD 3G Ventrassist.

A Device not a System.

http://www.ventracor.com/ventrassist/ventassist_productpr.asp

Cheers dma