Device Dossier
Suture, polypropylene monofilament
Device Dossier for Suture, polypropylene monofilament (Polyolefin/fluoropolymer suture, monofilament, Class III, sponsor Device Technologies). ARTG…
- GMDN category: Polyolefin/fluoropolymer suture, monofilament
- Sponsor: Device Technologies
Intended purpose
Premio sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular and vascular surgery, in ophthalmic surgery and in neurological surgery.
Functional description
The synthetic non-absorbable surgical sutures Premio are composed of a PVDF monofilament, with or without pledget of different sizes. Premio sutures elicit a minimal acute inflammatory reaction in tissues, which is followed by gradual encapsulation of the suture by fibrous connective tissue. Premio sutures are not absorbed and there is no degradation or loss of strength.