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Approval under section 42DF for use of restricted representations by Scoliosis Clinics Australia Pty Ltd
I, Leanne McCauley, Delegate of the Secretary to the Department of Health, on receipt of an application from Scoliosis Clinics Australia Pty Ltd have approved under section 42DF of the Therapeutic Goods Act 1989 (the Act) the restricted representations described in paragraph (A) below for use in advertisements directed to consumers, for the products identified in paragraph (B):
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- Representations which refer to scoliosis in the context of:
- The company "Scoliosis Clinics Australia Pty Ltd" and its trading name "ScoliCare Australia"; and
- The product name "Scolioscan" and "Scolioscan - 3D Ultrasound Scoliosis Assessment System".
- Representations which refer to scoliosis to the effect that the product is for the detection and monitoring of scoliosis[1].
- Representations which refer to scoliosis in the context of:
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- Scolioscan - 3D Ultrasound system, imaging, general-purpose (ARTG 297989)
Dated this 6th day of August 2019
Signed electronically
Leanne McCauley
Delegate of the Secretary to the Department of Health
Advertising Compliance Unit
Regulatory Education and Compliance Branch
Footnotes
| [1] | This approval only applies to representations that refer to the detection and monitoring of scoliosis. That is, this approval does not extend to any other claims within such representations such as the Device being "radiation free". |
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