Nevro Medical - HF-10

Therapeutic Goods Act 1989

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

I, Elizabeth Butt, as a delegate of the Secretary to the Department of Health, on receipt of an application from Nevro Medical 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 consumer advertising of the product identified in paragraph (B):

1. Representations to the effect that HF-10 may assist in the management of persistent lower limb pain associated with medically diagnosed diabetic peripheral neuropathy, which will always be accompanied by the following statements, prominently displayed or communicated^[1], and to the effect of the following:
   • this product is not a first-line treatment for the pain associated with diabetic peripheral neuropathy; and
   • surgery is required in order to use this product; and
   • any surgical procedure carries risk; and
   • talk to your health professional about whether this product may be suitable for you as part of your overall plan to manage diabetic peripheral neuropathy.
2. Product marketed as "HF-10" under the following entry in the Australian Register of Therapeutic Goods (ARTG):
   • Senza Omnia IPG kit - NIPG2500 - Stimulator, electrical, analgesic, spinal cord" (ARTG 330704) (the Device).

Dated this 16th day of June 2021

Signed electronically

Elizabeth Butt
Delegate of the Secretary to the Department of Health
Advertising and Compliance Education and Policy Section
Regulatory Compliance Branch