Circulatory assist unit, pump, balloon (Suspension from the ARTG under paragraph 41GFA(1)(b) of the Act)
Product name
Circulatory assist unit, pump, balloon [36340]
Sponsor
ARTG
118266
Date action takes effect
Compliance action
Medical device suspension
Type of action
Suspension from the ARTG under paragraph 41GFA(1)(b) of the Act
Grounds for regulatory action
Under paragraph 41FA(1)(b); the conformity assessment certification applying to the Device has been suspended by the Notified Body
Device names
Circulatory assist unit, pump, balloon [36340]
Suspension is effective until Secretary evokes it under subsection 41GH of the Act, or the person in relation to whom the kind of medical device is included in the Register provides the Secretary with another conformity assessment document that applies to the kind of device.