Infusion pump, syringe (T34L Models only) (Cancellation from the ARTG under subsection 41GM(2) of the Act. Cancellation will be limited to some medical devices of the kind (only T34L, T34L NeoFeed and T34L KID models) and the ARTG must be varied according
Product name
Infusion pump, syringe (T34L Models only)
Sponsor
ARTG
131232
Date action takes effect
Compliance action
Medical device cancellation - certain devices within an entry
Type of action
Cancellation from the ARTG under subsection 41GM(2) of the Act. Cancellation will be limited to some medical devices of the kind (only T34L, T34L NeoFeed and T34L KID models) and the ARTG must be varied accordingly under section 41GO of the Act.
Grounds for regulatory action
The response from a Section 41JA notification has informed that the device type is not supplied or imported in Australia, or exported from Australia.The grounds for cancellation apply only to T34L variants of infusion pumps (including T34L, T34L NeoFeed and T34L KID models) and the cancellation is limited under s41GO to vary ARTG 131232 accordingly.
Device names
T34L infusion pump, T34L NeoFeed infusion pump and T34L KID infusion pump