Device Dossier
Suture, polypropylene monofilament
Device Dossier for Suture, polypropylene monofilament (Polyolefin/fluoropolymer suture, monofilament, Class IIb, sponsor Boston Scientific). ARTG record,…
- GMDN category: Polyolefin/fluoropolymer suture, monofilament
Intended purpose
This Polypropylene Suture is comprised of sterile packaged non-absorbable polypropylene suture attached to an implantable anchor manufactured from cobalt chromium and stainless steel. The anchor component is intended to function with the OverStitch Endoscopic Suturing System to perform stitching operations and serves as an anchor to secure suture placement. The suture is manufactured from an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polyolefin. The suture pigment uses CU-Phthalocyanine Blue Dye (below 0.5 WT %) to enhance visibility. The suture material meets the requirements established by the USP.