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Left atrial appendage
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21	WATCHMAN Proposed Indication: WATCHMAN LAAC Therapy is indicated to prevent thromboembolism from the left atrial appendage. It may be considered for use in patients with non‐valvular atrial fibrillation who are eligibl Add to Reading List Source URL: www.fda.gov
22	The Panel will need to integrate information from multiple datasets (PREVAIL, PROTECT AF, and CAP) in order to determine whether the totality of the data demonstrate a reasonable assurance of device safety and effectiven Add to Reading List Source URL: www.fda.gov Language: English Hematology Stroke Interventional cardiology Left atrial appendage occlusion Atrial fibrillation CHADS2 score Warfarin Embolism Thrombosis Medicine Health Aging-associated diseases
23	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
24	Microsoft Word - P130013 panel 2 exec summary final.doc Add to Reading List Source URL: www.fda.gov Language: English Anticoagulants Hematology Interventional cardiology Left atrial appendage occlusion Cardiac dysrhythmia Apixaban Dabigatran Stroke CHADS2 score Chemistry Organic chemistry Medicine
25	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
26	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
27	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
28	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
29	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
30	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

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