Device Dossier

DuraMatrix-Onlay Collagen dura Substitute Membrane - Dura mater biomatrix implant

Device Dossier for DuraMatrix-Onlay Collagen dura Substitute Membrane - Dura mater biomatrix implant (Dura mater biomatrix implant, Class III, sponsor…

Intended purpose

Collagen Dura Substitute Membrane is indicated as a dura substitute for the repair of dura mater.

Functional description

Collagen Dura Substitute membrane is a white, nonfriable, conformable resorbable, membrane matrix engineered from highly purified type I collagen derived from bovine Achilles tendon. The device has a thickness similar to that of native dura. It is flexible and conforms to the contours of the defect site. The conformability of the membrane allows it to be applied as an onlay device, DuraMatrix Onlay is supplied Sterile, non-pyrogenic, in various sizes and for single use only.

TGA Public Summary