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