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Cancellation or suspensionRegulatory action due to The sponsor has failed to comply with an automatic condition of inclusion applied to this ARTG entry under subsection 41FN(5A) of Therapeutic Goods Act 1989 and regulation 5.11 of Therapeutic Goods (Medical Devices) Regulations 2002, to provide information about the safety and performance of the Devices by 1 October each year for three consecutive years after the inclusion., effective 20/11/2020