FDAnews Device Daily Bulletin
Medical Devices / Commercial Operations

Two BTG Products Get CE Mark Reclassifications as Class III Devices

Aug. 3, 2016
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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

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