Device Dossier

Gore BIO-A Tissue Reinforcement - Mesh, polymeric, biodegradable

Device Dossier for Gore BIO-A Tissue Reinforcement - Mesh, polymeric, biodegradable (Mesh, polymeric, biodegradable, Class III, sponsor W L Gore &…

Intended purpose

The GORE BIO-A Tissue Reinforcement is intended for use in the reinforcement of soft tissue.

Functional description

Rectangular sheets of porous, fibrous mesh. The Instructions for Use indicate that this device is a tailorable, synthetic, bioabsorbable material intended to be a temporary bridge of defects until the bioabsorbable nature of the device allows the body to fill the defect with native tissue. In repairs requiring high strength, a permanent overlay patch is strongly recommended.

TGA Public Summary