08:52 AM EDT, 07/08/2024 (MT Newswires) -- Pulse Biosciences ( PLSE ) said Monday that the US Food and Drug Administration granted Breakthrough Device Designation to its nsPFA cardiac surgery system for the ablation of cardiac tissue to treat atrial fibrillation.
The company said it plans to seek FDA approval through the premarket approval (PMA) pathway to market its nsPFA Cardiac Surgical System for the treatment of atrial fibrillation in the US, following which it plans to begin commercialization.
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