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FDA Regulatory Disclosure
The educational and informational materials presented on this website refer to a cryoablation device for local treatment of low-risk breast cancer classified under 21 CFR 878.4355. In strict accordance with the federal De Novo marketing authorization granted to this technology, the system is explicitly indicated for the local treatment of early-stage, low-risk breast cancer when combined with adjuvant endocrine therapy for women aged 70 and over.