Cement, orthopaedic, bone (Cancelled from the ARTG under s41GK and 41GO)
Product name
Cement, orthopaedic, bone
Sponsor
ARTG
152441
Date action takes effect
Compliance action
Medical device cancellation - certain devices within an entry
Type of action
Cancelled from the ARTG under s41GK and 41GO
Grounds for regulatory action
The Device has been cancelled as the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension is revoked. The sponsor did not provide evidence that the device complies with Essential Principles 1 and 6 prior to the expiry of the suspension period.The grounds for cancellation apply only to SerenoCem Granules BCG050 (the Device) and the cancellation is limited under s41GO to vary ARTG 152441 accordingly.
Device names
SerenoCem Granules BCG050