Device Dossier
SenoMark Ultra Breast Tissue Marker - Biodur - Marker, lesion localization, implantable
Device Dossier for SenoMark Ultra Breast Tissue Marker - Biodur - Marker, lesion localization, implantable (Marker, lesion localization, implantable,…
- GMDN category: Marker, lesion localization, implantable
Intended purpose
An implant used to radiographically and sonographically mark breast tissue during a percutaneous breast biopsy procedure.
Functional description
Disposable applicator with 3 resorbable PGA pads, each containing a coil shaped Biodur wireform with an interwoven PVA polymer.Pads assist in accurate placement of the marker until they are resorbed in approx 12 weeks.A polyethylene glycol push pellet is present at the end.The wireform is intended for long-term radiographic marking of the biopsy site.The PVA polymer is intended for long-term sonographic marking of the biopsy site.Applicator fits in a biopsy probe to access the body cavity.