Clinical Study Designs for Catheter Ablation Devices for Treatment of Atrial Flutter: Guidance for Industry and FDA Staff
Information
Type
Guidance
Regulated products
Medical Devices
Topics
Good Clinical Practice (GCP), Premarket
Published
August 5, 2008
Last updated
March 24, 2020
Description
This document is a guidance for industry and FDA staff on clinical study designs for catheter ablation devices used to treat atrial flutter.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)