Covidien - Blood pressure monitors incorporating atrial fibrillation detection technology

Therapeutic Goods Act 1989

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

I, Jane Cook, Head, Post-market Surveillance Branch, Therapeutic Goods Administration and delegate of the Secretary to the Department of Health, on receipt of an application from Covidien 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):

1.  
   1. atrial fibrillation is an arrhythmia that can be asymptomatic and intermittent and can lead to stroke;
   2. the device referred to in paragraph (b) is a reliable screening tool that can detect atrial fibrillation;
   3. early detection/diagnosis of atrial fibrillation enables a doctor to start appropriate treatment, which may prevent stroke;
   4. hypertension is a risk factor for atrial fibrillation;
   5. of stating accurate and current age-related prevalence of atrial fibrillation; and
   6. of stating the prevalence of stroke cases due to atrial fibrillation
2. Blood pressure monitors incorporating atrial fibrillation detection technology (ARTG 204268)

Dated this 23rd day of April 2015

Dr Jane Cook
Delegate of the Secretary to the Department of Health; and
Head
Post-market Surveillance Branch