Overview of the food and drug administration circulatory system devices panel meetings on WATCHMAN left atrial appendage closure therapy

American Journal of Cardiology

Volumn 115, Issue 3, 2015, Pages 378-384

  Waksman, Ron ^a   Pendyala, Lakshmana K ^a  

^a WASHINGTON HOSPITAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

WARFARIN; ANTICOAGULANT AGENT;

ARTICLE; BRAIN ISCHEMIA; CARDIOVASCULAR RISK; DEVICE SAFETY; FOLLOW UP; FOOD AND DRUG ADMINISTRATION; HEART ATRIUM FIBRILLATION; HUMAN; LEARNING CURVE; LEFT ATRIAL APPENDAGE CLOSURE DEVICE; LONG TERM CARE; MEDICAL DEVICE COMPLICATION; OUTCOME ASSESSMENT; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL (TOPIC); ATRIAL FIBRILLATION; COMPLICATION; DEVICE APPROVAL; EMBOLISM; HEART ATRIUM APPENDAGE; PROSTHESES AND ORTHOSES; RISK ASSESSMENT; SEPTAL OCCLUDER; STROKE; SURGERY; UNITED STATES;

ANTICOAGULANTS; ATRIAL APPENDAGE; ATRIAL FIBRILLATION; DEVICE APPROVAL; EMBOLISM; HUMANS; PROSTHESES AND IMPLANTS; RISK ASSESSMENT; SEPTAL OCCLUDER DEVICE; STROKE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; WARFARIN;

EID: 84920699958     PISSN: 00029149     EISSN: 18791913     Source Type: Journal    
DOI: 10.1016/j.amjcard.2014.11.011     Document Type: Review

References (8)

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.
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