Score femoral component PCL sacrificing - cementless HA coated (Cancellation from the ARTG under s.41GN(1)(b))
Product name
Score femoral component PCL sacrificing - cementless HA coated
Sponsor
ARTG
210576
Date action takes effect
Compliance action
Medical device cancellation
Type of action
Cancellation from the ARTG under s.41GN(1)(b)
Grounds for regulatory action
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 s.41FN(3)(a).The sponsor was notified of the cancellation under s.41GN(1)(b) on 7 December 2021. Prior to the cancellation taking effect on 14 January 2022, 20 working days after the notification of the cancellation (s.41GQ), the sponsor requested the cancellation of the ARTG inclusion under s.41GL(d).