t:slim X2 insulin pump/Infusion pump, insulin, ambulatory (Suspension from the ARTG under s.41GA(1)(b))
Product name
t:slim X2 insulin pump/Infusion pump, insulin, ambulatory
Date action takes effect
Lapse date
Compliance action
Medical device suspension
Type of action
Suspension from the ARTG under s.41GA(1)(b)
Grounds for regulatory action
Under subsection 41GA(1)(b); it is likely that there are grounds for cancelling this kind of device from the ARTG under subsection 41GN(1)(b) & (1)(e).
Revocation of suspension effective 1 April 2021.
Revocation of suspension from the ARTG under s.41GD.
Under subsection 41GD; the grounds for cancelling this kind of device from the ARTG under subsection 41GN(1)(b) & (1)(e) no longer apply.
Further information about this device is available in a related safety alert.