Getinge Australia Pty Ltd - Heat exchanger, heart-lung bypass (144010)

Regulatory action due to As the sponsor did not provide information under section 41JA of the Act, the sponsor failed to comply with a condition to which inclusion of the kind of medical device in the ARTG was subject under section 41FN(3)(c) of the Act. 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 section 41FN(2) of the Act. 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 section 41FN(3)(a) of the Act. However, as other devices of the same kind are included under the ARTG entry, the entry has been varied to exclude these devices. Other devices under the entry remain., effective 25/07/2017