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

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

Functional description

Clear or pigmented, non-absorbable sterile suture composed of an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polyolefin. The suture is pigmented blue to enhance visibility. This diameters of the suture strand and needle wire have been aligned to reduce the degree of needle hole bleeding.

TGA Public Summary