Furlong Evolution Collared Femoral Stem (Cancellation from the ARTG under s.41GN(1)(b))
Product name
Furlong Evolution Collared Femoral Stem
Sponsor
ARTG
302742
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
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 s.41FN(3)(a).