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Guidance Documents/Guidance-Document/Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation - Guidance for Industry and Food and Drug Administration Staff

Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation - Guidance for Industry and Food and Drug Administration Staff

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

February 14, 2013

February 28, 2020

Center for Devices and Radiological Health

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