www.fdanews.com/articles/177787-two-btg-products-get-ce-mark-reclassifications-as-class-iii-devices
Two BTG Products Get CE Mark Reclassifications as Class III Devices
August 2, 2016
DC Bead and DC Bead M1 have been reclassified as Class III medical devices.
These devices are embolic drug-eluting beads capable of loading and releasing compatible chemotherapeutic agents.
These drug administrators are the only drug-eluting beads with CE Mark approval for filling with doxorubicin and irinotecan, according to the company. — Cynthia Jessup