This article was originally published in The Gray Sheet
Surgical cardiac tissue ablation system will begin U.S. shipping in January; the firm announced 510(k) clearance Dec. 13. MedicalCV plans a trial for an atrial fibrillation claim (1"The Gray Sheet" Nov. 29, 2004, p. 18)...
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MedicalCV will conduct an IDE clinical study to investigate its Atrilaze soft tissue ablation system for cardiac arrhythmias, following an initial 510(k) clearance
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