3T heater-cooler device (Revocation of suspension from the ARTG under section 41GD of the Therapeutic Goods Act 1989 (the Act).)
Product name
3T heater-cooler device
Sponsor
Date action takes effect
Lapse date
Compliance action
Medical device suspension
Type of action
Revocation of suspension from the ARTG under section 41GD of the Therapeutic Goods Act 1989 (the Act)
Grounds for regulatory action
Pursuant to subsection 41GA(1)(b) of the Act, there are likely grounds for cancelling the ARTG entry, in accordance with paragraphs 41GN(1)(f) and 41GN(1)(b) of the Act.
A decision to extend the suspension period for an additional 6 months was made in accordance with section 41GC of the Act.
A decision to revoke the suspension of the entry from the ARTG was made on 18 September 2018 as the conditions under section 41GD(1)(a) of the Act had been met; the grounds for cancelling the ARTG entry no longer apply.