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Autologous adipose tissue collection/washing set (Suspension of the kind of device under s41GA(1)(b))
Product name
Autologous adipose tissue collection/washing set
Sponsor
ARTG details
- 226117
Date action takes effect
Lapse date
Compliance action
Medical device suspension
Type of action
Suspension of the kind of device under s41GA(1)(b)
Grounds for regulatory action
Pursuant to section 41GA(1)(b) of the Act, the Secretary has suspended the device as it is likely there are grounds for cancelling the device from the Register under Division 2 (other than under paragraph 41GL(a) or (d) or section 41GM).
The Secretary is satisfied there are grounds for cancelling the device from the Register under subsection 41GN(1)(b) because the Sponsor has failed to comply with the conditions of inclusion set out under subsections 41FN(3)(b) and (c).