Medtronic Australasia Pty Ltd - Guardian 4 Sensor – Subcutaneous glucose sensor and Invasive interstitial-fluid glucose monitoring system

Therapeutic Goods Act 1989

Approval under section 42DF for use of restricted representations by Medtronic Australasia Pty Ltd

I, Michael Shum, as a delegate of the Secretary to the Department of Health and Aged Care, on receipt of an application from Medtronic Australasia Pty Ltd, have approved under section 42DF of the Therapeutic Goods Act 1989, the restricted representations described in paragraph (A), for use in advertising the products identified in paragraph (B) to consumers.

• Representations referring to “diabetes” in the context of the name “Medtronic Diabetes”
• The Guardian 4 sensor is intended for use with a Guardian 4 transmitter to monitor glucose levels in persons with diabetes where self-monitoring of blood glucose (SMBG) is indicated
• The sensor is designed to replace fingerstick blood glucose (BG) readings for diabetes treatment decisions
• The sensor is intended for insertion into persons with diabetes ages 7 years and older.
• Diabetes management with no calibrations (the Calibration statement)
  
  Whenever the ‘Calibration statement’ is used in consumer advertising an advisory statement to the effect “if sensor glucose (SG) values do not match symptoms or expectations, use a blood glucose meter to make diabetes treatment decisions. Refer to System User Guide” will be prominently displayed or communicated adjacent or in close proximity to the Calibration statement.

• Guardian 4 Sensor – Subcutaneous glucose sensor (ARTG 405150)
• Invasive interstitial-fluid glucose monitoring system (ARTG 374791)
  together, (the Device System).

Dated this 26th day of April 2023

Signed electronically

Michael Shum

Delegate of the Secretary to the Department of Health and Aged Care
Advertising and Compliance Education and Policy Section
Regulatory Compliance Branch