Device Dossier
PROLENE Polypropylene Suture - Suture, polypropylene monofilament
Device Dossier for PROLENE Polypropylene Suture - Suture, polypropylene monofilament (Polyolefin/fluoropolymer suture, monofilament, Class III, sponsor…
- GMDN category: Polyolefin/fluoropolymer suture, monofilament
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.