Mesh, polymeric, non-biodegradable (Restorelle DirectFix Anterior and Restorelle DirectFix Posterior) (Cancelled from the ARTG under s.41GN(1)(e) and the ARTG entry varied under s.41GO)
Product name
Mesh, polymeric, non-biodegradable (Restorelle DirectFix Anterior and Restorelle DirectFix Posterior)
Sponsor
ARTG
190172
Date action takes effect
Compliance action
Medical device cancellation - certain devices within an entry
Type of action
Cancelled from the ARTG under s.41GN(1)(e) and the ARTG entry varied under s.41GO
Grounds for regulatory action
Cancelled on the basis that the Secretary is satisfied that the safety and performance of some devices included in the entry are unacceptable. However, as other devices of the same kind are included under the ARTG entry, the entry has been varied to exclude these devices: Restorelle DirectFix Anterior and Restorelle DirectFix Posterior.
Device names
Restorelle DirectFix Anterior and Restorelle DirectFix Posterior