Deflux - Urinary tissue reconstructive material

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Palette Life Sciences Australia Pty Ltd

Class:

Class III

Manufactured by:

Palette Life Sciences 27 E Cota Street Suite 402, Santa Barbara, CA, 93101 United States Of America

Therapeutic area:

60700 - Urinary tissue reconstructive material

Therapeutic indications:

Deflux is a sterile, injectable medical device implant for submucosal injection in the urinary tract. It is a viscous gel of dextranomer microspheres and stabilized hyaluronic acid of non-animal origin constituting a biocompatible and biodegradable implant. The stabilized hyaluronic acid acts mainly as a carrier, leaving the dextranomer microspheres at the implant site where they are gradually surrounded by host connective tissue. Deflux is supplied in a glass syringe marked at 0.1 mL intervals Deflux is intended for submucosal injections in the urinary bladder and distal ureter.

Authorization status:

A

Authorization date:

2020-10-12