LivaNova Australia Pty Ltd - Heating unit, pad, water, system (194514)

Regulatory action due to Pursuant to subsection 41GA(1)(b) of the Act, there are likely grounds for cancelling the ARTG entry, in accordance with paragraphs 41GN(1)(f) and 41GN(1)(b) of the Act., effective 08/11/2017

Regulatory action due to As the sponsor did not provide information under 41JA, the sponsor failed to comply with a condition to which inclusion of the kind of medical device in the ARTG was subject under 41FN (3)(C). As the sponsor did not provided a sample, the sponsor failed to comply with a condition to which inclusion of the kind of medical device in the ARTG was subject under 41FN(2). As the sponsor did not provide evidence to demonstrate compliance with the Essential Principles, the sponsor failed to comply with a condition to which inclusion of the kind of medical device in the ARTG was subject under 41FN(3)(a). However, as other devices of the same kind are included under the ARTG entry, the entry has been varied to exclude these devices: Flextherm and Stockert Heater-Cooler 1T., effective 04/07/2017