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Appendage
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41	Appendix E: Entrance Criteria PROTECT AF Study Inclusion Criteria A patient was enrolled in the study if all of the following inclusion criteria were met: – The patient is 18 years of age or older Add to Reading List Source URL: www.fda.gov Language: English Hematology Stroke Aging-associated diseases Valvular heart disease Interventional cardiology Left atrial appendage occlusion Warfarin Atrial fibrillation Atrial septal defect Medicine Health Circulatory system
42	Appendix D: Summary of WATCHMAN Studies Four additional clinical studies have been conducted on the WATCHMAN device as follows (in order of relevance): Study Enrollment Add to Reading List Source URL: www.fda.gov Language: English Circulatory system Left atrial appendage occlusion CHADS2 score Stroke Left atrial appendage Clinical trial Atrial fibrillation Warfarin Thrombus Medicine Health Interventional cardiology
43	WATCHMAN™ Left Atrial Appendage Closure (LAAC) Technology for Patients with NonValvular Atrial Fibrillation Circulatory System Devices Panel Meeting October 8, 2014 Table of Contents FDA Executive Summary Add to Reading List Source URL: www.fda.gov
44	WATCHMAN™ Left Atrial Appendage Closure (LAAC) Technology for Patients with NonValvular Atrial Fibrillation Sponsor’s Executive Summary P130013 Circulatory System Devices Panel Meeting October 8, 2014 Add to Reading List Source URL: www.fda.gov Language: English Ketones Atrial fibrillation Cardiac dysrhythmia CHADS2 score Left atrial appendage occlusion Clinical endpoint Stroke Warfarin Food and Drug Administration Medicine Health Chemistry
45	Protocol Synopsis PREVENT-PAS Objective(s) The WATCHMAN Post Approval Study is designed to assess long term safety and effectiveness outcomes associated with the use and implantation of the WATCHMAN Add to Reading List Source URL: www.fda.gov Language: English Ketones Aging-associated diseases Interventional cardiology Left atrial appendage occlusion Bristol-Myers Squibb Prasugrel Stroke Atrial fibrillation Left atrial appendage Chemistry Medicine Organic chemistry
46	Microsoft Word - 003_Proposed SSED.doc Add to Reading List Source URL: www.fda.gov Language: English Interventional cardiology Left atrial appendage occlusion Left atrial appendage Atrial fibrillation Sony Watchman Medical device Percutaneous Biocompatibility Catheter Medicine Technology Surgery
47	DRAFT This artwork is not ready for release until this note is removed. The Date-of-Issue will not be populated until this draft note is removed. Add to Reading List Source URL: www.fda.gov Language: English Hematology Aging-associated diseases Stroke Interventional cardiology Left atrial appendage occlusion Cardiac dysrhythmia Dabigatran Atrial fibrillation Warfarin Medicine Chemistry Organic chemistry
48	Appendix J: Overview of Physician Training Program The WATCHMAN physician training program was used in the Prospective Randomized Evaluation of the WATCHMAN LAA Closure Device in Patients with Atrial Fibrillation versus Add to Reading List Source URL: www.fda.gov Language: English Medical technology Interventional cardiology Left atrial appendage occlusion Simulation Surgical technologist Implant Sony Watchman Medicine Technology Prosthetics
49	WATCHMAN Left Atrial Appendage Closure (LAAC) Technology FDA Review of P130013 Rachel Neubrander, PhD Division of Cardiovascular Devices Office of Device Evaluation Add to Reading List Source URL: www.fda.gov Language: English Anatomy Interventional cardiology Left atrial appendage occlusion Cardiac dysrhythmia Atrial fibrillation Warfarin Embolism CHADS2 score Thrombosis Medicine Hematology Circulatory system
50	Circulatory System Devices Advisory Panel October 8, 2014 Voting Questions Boston Scientific WATCHMAN® Left Atrial Appendage Closure Therapy Add to Reading List Source URL: www.fda.gov Language: English Circulatory system Medicine Technology Left atrial appendage Atrium Atrial fibrillation Sony Watchman Stroke Interventional cardiology Left atrial appendage occlusion Cardiac dysrhythmia

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