Device Dossier

PDS II (Polydioxanone) Suture - Suture, polydioxanone

Device Dossier for PDS II (Polydioxanone) Suture - Suture, polydioxanone (Suture, polydioxanone, Class III, sponsor Johnson & Johnson Medical). ARTG…

Intended purpose

PDS sutures are indicated for use in soft tissue approximation, including use in paediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. PDS II suture is not indicated in adult cardiovascular tissue, microsurgery and neural tissue.

Functional description

PDS II (polydioxanone) monofilament synthetic absorbable suture is prepared from the polyester, poly(p-dioxanone). Polydioxanone polymer has been found to be nonallergenic, nonpyrogenic and elicits only a slight tissue reaction during absorption. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable.

TGA Public Summary