Endotherapeutics Pty Ltd

Regulatory action due to Under subsection 41GA(1)(b); there is likely that there are grounds for cancelling this device from the ARTG under subsection GN(1)(b)., effective 31/08/2017

Regulatory action due to Cancelled by Secretary - As the sponsor did not provide information to substantiate compliance with the Essential Principles, the sponsor failed to comply with a condition to which inclusion of the kind of device in the ARTG was subject under s41FN(3)(a)., effective 11/08/2017

Regulatory action due to Cancelled by Secretary - As the sponsor did not provide information to substantiate compliance with the Essential Principles, the sponsor failed to comply with a condition to which inclusion of the kind of device in the ARTG was subject under s41FN(3)(a)., effective 11/08/2017