Overview of the Food and Drug Administration Circulatory System Devices Panel Meetings on WATCHMAN Left Atrial Appendage Closure Therapy

Author:

Waksman Ron,Pendyala Lakshmana K.

Publisher

Elsevier BV

Subject

Cardiology and Cardiovascular Medicine

Reference8 articles.

1. A meeting of the Circulatory System Devices Panel on April 23, 2009, to discuss and vote on the premarket approval application for the Atritech, Inc. WATCHMAN® left atrial appendage closure technology. Meeting Materials of the Circulatory System Devices panel. Available at: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/ucm152596.htm. Accessed on June 15, 2014.

2. The Circulatory System Devices Panel of the Medical Devices Advisory Committee to the Food and Drug Administration meeting on December 11, 2013 to make recommendations related to premarket approval application regarding the Boston Scientific WATCHMAN Left Atrial Appendage Closure Therapy. Meeting Materials of the Circulatory System Devices Panel. Available at: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/ucm342357.htm. Accessed on June 15, 2014.

3. Issue Highlights

4. US Food and Drug Administration. FDA Executive Summary: Boston Scientific WATCHMAN® left atrial appendage closure therapy. Prepared for the October 8, 2014, meeting of the Circulatory System Devices Panel (P130013). Available at: www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM417199.pdf.

5. Dabigatran versus warfarin in patients with atrial fibrillation;Connolly;N Engl J Med,2009

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