Suture, polytetrafluoroethylene (Cancellation from the ARTG under s.41GN(1)(b))
Product name
Suture, polytetrafluoroethylene
ARTG
303441
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).