Cardiopulmonary bypass system heating/cooling unit (Suspension from the ARTG under s.41GA(1)(b))
Product name
Cardiopulmonary bypass system heating/cooling unit
ARTG
262576
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 there are grounds for cancelling this kind of device from the ARTG under subsection 41GN(1)(b).
A decision to extend the suspension period for an additional 6 months effective 02/12/2017 was made in accordance with section 41GC of the Therapeutic Goods Act 1989.
Following the submission of adequate evidence, the suspension has been revoked in accordance with section 41GD of the Act on 31 May 2018.