Radiesse Injectable Implant - Tissue reconstructive material, synthetic, fluid

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Merz Australia Pty Ltd

Class:

Class III

Manufactured by:

Merz North America Inc 4133 Courtney Street Suite 10, Franksville, WI, 53126 United States Of America

Therapeutic area:

17876 - Tissue reconstructive material, synthetic, fluid

Therapeutic indications:

RADIESSE injectable implant is a steam sterilised, semi-solid implant created by suspending calcium hydroxylapatite in a gel carrier consisting primarily of sterile water for injection (USP) and glycerin (USP). The gel structure is formed by adding sodium carboxymethylcellulose (USP). The gel dissipates in vivo, replaced with soft tissue growth, while the calcium hydroxylapatite remains at the injection site. The result is long-term yet non-permanent restoration and augmentation. Radiesse Injectable Implant (Part Number 8071M19) is indicated for plastic and reconstructive surgery, including deep dermal and sub dermal soft tissue augmentation of the facial area, and is also intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus.

Authorization status:

A

Authorization date:

2013-02-13