Overview of the 2011 Food and Drug Administration Circulatory System Devices Panel of the medical devices advisory committee meeting on the CardioMEMS Champion Heart Failure Monitoring System

Journal of the American College of Cardiology

Volumn 61, Issue 15, 2013, Pages 1571-1576

  Loh, Joshua P ^a   Barbash, Israel M ^a   Waksman, Ron ^a  

^a WASHINGTON HOSPITAL CENTER   (United States)

Author keywords

Food and Drug Administration; heart failure; pulmonary artery pressure monitoring

Indexed keywords

AMBULATORY CARE; CIRCULATORY SYSTEM DEVICE; FOOD AND DRUG ADMINISTRATION; HEART FAILURE; HEART RATE; HUMAN; IMPLANT; LENGTH OF STAY; LUNG ARTERY PRESSURE; MEDICAL DEVICE; PATIENT MONITORING; PATIENT SAFETY; PRIORITY JOURNAL; REVIEW;

ADVISORY COMMITTEES; BLOOD PRESSURE MONITORING, AMBULATORY; BLOOD PRESSURE MONITORS; DEVICE APPROVAL; ELECTRODES, IMPLANTED; FEMALE; HEART FAILURE; HUMANS; LENGTH OF STAY; MALE; OUTCOME AND PROCESS ASSESSMENT (HEALTH CARE); PATIENT SELECTION; PULMONARY WEDGE PRESSURE; RESEARCH DESIGN; UNITED STATES;

EID: 84876022482     PISSN: 07351097     EISSN: 15583597     Source Type: Journal    
DOI: 10.1016/j.jacc.2012.08.1035     Document Type: Review

References (4)

1. US Food and Drug Administration 2011 Meeting Materials of the Circulatory System Devices Panel - continued http://www.fda.gov/AdvisoryCommittees/ CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ CirculatorySystemDevicesPanel/ucm276551.htm Accessed December 22, 2012
2. W.T. Abraham, P.B. Adamson, R.C. Bourge Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial Lancet 377 2011 658 666
3. U.S. Food and Drug Administration FDA Executive Summary - Addendum Presented December 8, 2011, at Gaithersburg MD http://www.fda.gov/downloads/ AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/ MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM282272.pdf Accessed December 9, 2011
4. H. Krum Telemonitoring of fluid status in heart failure: CHAMPION Lancet 377 2011 616 618