Heat exchanger, heart-lung bypass (Suspension from the ARTG under s.41GA(1)(b))
Product name
Heat exchanger, heart-lung bypass
Sponsor
ARTG
135587
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
Pursuant to subsection 41GA(1)(b) of the Act, there are likely grounds for cancelling this ARTG entry, in accordance with subsection 41GN(1)(b) of the Act. The suspension from the ARTG was effective on 5 April 2018 for a period of six months.
Summary of change to conditions: A decision to extend the suspension period for an additional 6 months was made in accordance with subsection 41GC(3) of the Act on 5 October 2018.
Further information: ARTG 135587 was cancelled from the Register by the sponsor on 29 March 2019.