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

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Premarket

Published

February 14, 2013

Last updated

February 28, 2020

Description

This is a guidance document by the FDA on clinical study designs for surgical ablation devices used in treating atrial fibrillation.

Organization

Country / Region

United States

License

Other (Public Domain)

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