Cardiac resynchronization devices: The Food and Drug Administration's regulatory considerations

Journal of the American College of Cardiology

Volumn 46, Issue 12, 2005, Pages 2325-2328

  Moynahan, Megan ^a,b   Faris, Owen P ^a   Lewis, Brian M ^a  

^a CENTER FOR DEVICES AND RADIOLOGICAL HEALTH   (United States)

^b CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BLOOD VESSEL GRAFT; CARDIAC RESYNCHRONIZATION THERAPY; DEFIBRILLATOR; DEVICE; FOOD AND DRUG ADMINISTRATION; HEART FAILURE; HOSPITALIZATION; HUMAN; MARKET; PACEMAKER; PRIORITY JOURNAL; QUALITY OF LIFE; REVIEW; RISK ASSESSMENT; TREATMENT INDICATION; VALIDATION PROCESS;

BIOMEDICAL TECHNOLOGY; CARDIAC OUTPUT, LOW; CLINICAL TRIALS; DEVICE APPROVAL; HUMANS; PACEMAKER, ARTIFICIAL; PRODUCT SURVEILLANCE, POSTMARKETING; RESEARCH DESIGN;

EID: 28944445597     PISSN: 07351097     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jacc.2005.04.068     Document Type: Review

References (8)

1. Code of Federal Regulations [USA]. Title 21, part 860.7(e).
2. Food and Drug Administration Summary of Safety and Effectiveness, Medtronic InSync 2005 Available at: http://www.fda.gov/cdrh/pdf/P010015b.pdf. Accessed October 19, 2005.
3. Food and Drug Administration Summary of Safety and Effectiveness, Guidant Contak CD 2005 Available at: http://www.fda.gov/cdrh/pdf/P010012b.pdf. Accessed October 19, 2005
4. Food and Drug Administration Summary of Safety and Effectiveness, Medtronic InSync ICD 2005 Available at: http://www.fda.gov/cdrh/pdf/P010031b. pdf. Accessed October 19, 2005
5. Code of Federal Regulations [USA]. Title 21, part 860.7(d).
6. J.G. Cleland, J.C. Daubert, E. Erdmann The effect of cardiac resynchronization on morbidity and mortality in heart failure N Engl J Med 352 2005 1539 1549
7. M.R. Bristow, L.A. Saxon, J. Boehmer Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure N Engl J Med 350 2004 2140 2150
8. W.H. Maisel, M.O. Sweeney, W.G. Stevenson Recalls and safety alerts involving pacemakers and implantable cardioverter-defibrillator generators JAMA 286 2001 793 799