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

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Disponible depuis:

Bard Australia Pty Ltd

classe:

Class III

Fabriqué par:

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

Domaine thérapeutique:

40808 - Marker, lesion localization, implantable

indications thérapeutiques:

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.

Statut de autorisation:

A

Date de l'autorisation:

2009-03-11