Device Dossier

FILAPRON™ - Suture Poliglecaprone - Suture, polydioxanone

Device Dossier for FILAPRON™ - Suture Poliglecaprone - Suture, polydioxanone (Suture, polydioxanone, Class III, sponsor Meril). ARTG record, intended…

Intended purpose

Intended for use in general approximation and/or ligation of soft tissues where an absorbable material is indicated.

Functional description

Sterile, synthetic absorbable monofilament suture attached to standard stainless-steel needles. Available undyed clear and dyed violet to enhance visibility in tissue. Leads to ingrowth of fibrous connective tissue due to minimal initial inflammatory tissue reaction. It gradually loses tensile strength and is absorbed by hydrolytic process. Complete absorption usually takes place between 90 to 120 days.

TGA Public Summary