Device Dossier

Prolene Polypropylene Suture - Suture, polypropylene monofilament

Device Dossier for Prolene Polypropylene Suture - Suture, polypropylene monofilament (Polyolefin/fluoropolymer suture, monofilament, Class III, sponsor…

Intended purpose

For use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurosurgical procedures.

Functional description

Suture is a monofilament, synthetic, non-absorable sterile suture composed of polypropylene. Available in a range of gauze sizes and lengths attached to stainless steal needles of various types and sizes. In a magnet field the needles are bicolour (silver/black) and the labelling shows MRI. The sutures elicits a minimal initial inflammatory reaction in tissues which is followed by gradual encapsulation of the suture by fibrous connective tissue.

TGA Public Summary