Oventus - O2Vent Mono and O2 Vent Titratable

Therapeutic Goods Act 1989

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

I, Leanne McCauley, Director, Advertising Compliance Unit, Regulatory Practice, Education and Compliance Branch and Delegate of the Secretary to the Department of Health, on receipt of an application from Oventus 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 product identified in paragraph (b), provided the condition identified in paragraph (c) and (d) are met:

1. The efficacy statements:
   • may be suitable treatment for obstructive sleep apnoea for some patients
   • may be suitable for some people who are intolerant to CPAP
   • may be suitable for people with and without nasal obstructions
2. O₂Vent Mono (ARTG No. 230890) and O₂Vent Titratable (ARTG No. 275667)
3. in conjunction with cautionary statements to the effect of:
   • This form of treatment is not generally accepted as the first line treatment for sleep apnoea; and
   • Diagnosis and monitoring by a suitably qualified healthcare professional is required.
4. This approval is subject to the condition that the cautionary statements detailed in (c) above must be:
   • Displayed directly alongside the efficacy statements detailed in (a); and
   • Emphasised so as to be easily read from a normal viewing distance, and/or heard and understood.

Dated this 2nd day of November 2016

Leanne McCauley
Delegate of the Secretary to the Department of Health; and
Director
Advertising Compliance Unit
Regulatory Practice, Education and Compliance Branch