Medtronic Australasia Pty Ltd - Specify SureScan MRI 2x8 Surgical Lead Kit - Stimulator, electrical, analgesic, spinal cord (Cancellation from the ARTG under subsection 41GN(1) of the Act)
Product name
Medtronic Australasia Pty Ltd - Specify SureScan MRI 2x8 Surgical Lead Kit - Stimulator, electrical, analgesic, spinal cord
Sponsor
ARTG
280180
Date action takes effect
Compliance action
Medical device cancellation
Type of action
Cancellation from the ARTG under subsection 41GN(1) of the Act
Grounds for regulatory action
The sponsor did not provide sufficient information to substantiate compliance with the Essential Principles, the sponsor failed to comply with a condition to which inclusion of the kind of device in the ARTG was subject.