Gel Mark Ultra Biopsy Site Marker - Marker, lesion localization, implantable

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Commercializzato da:

Bard Australia Pty Ltd

Classe:

Class III

Prodotto da:

SenoRx Inc 1625 W 3rd Street, Tempe, AZ, 82581 United States Of America

Area terapeutica:

40808 - Marker, lesion localization, implantable

Indicazioni terapeutiche:

A disposable applicator containing resorbable polylactic acid/polyglycolic acid (PLA/PGA) pellets with an embedded titanium radiopaque wireform, intended for long term radiographic marking of the biospy site. Pellets are visible via ultrasound for approx. 6 weeks and resorbed in approx. 12 weeks. The pellets are deployed from the applicator through the biopsy device into the biopsy cavity. An implant used to radiographically mark breast tissue during a percutaneous breast biopsy procedure.

Stato dell'autorizzazione:

A

Data dell'autorizzazione:

2009-03-11