Cardiopulmonary bypass system heating/cooling unit (Suspension from the ARTG under s.41GA(1)(b))
Product name
Cardiopulmonary bypass system heating/cooling unit
ARTG
278698
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); there is likely that there are grounds for cancelling this kind of device from the ARTG under subsection GN(1)(b).
A decision to extend the suspension period for an additional 6 months was made in accordance with section 41GC of the Therapeutic Goods Act 1989.
The suspension has been revoked in accordance with section 41 GD of the Act on 20 April 2018.