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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceEPIC AND ATLAS+ HF CRT-D SYSTEMS
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP030054
Supplement NumberS010
Date Received06/06/2005
Decision Date11/18/2005
Product Code NIK 
Docket Number 05M-0492
Notice Date 12/19/2005
Advisory Committee Cardiovascular
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE MODIFICATION OF THE INDICATIONS FOR THE EPIC AND ATLAS+ HF CRT-D SYSTEMS, SPECIFICALLY THE MAINTENANCE OF SYNCHRONY OF THE LEFT AND RIGHT VENTRICLES IN PATIENTS WHO HAVE UNDERGONE AN AV NODAL ABLATION FOR CHRONIC (PERMANENT) ATRIAL FIBRILLATION AND HAVE NYHA CLASS II OR III HEART FAILURE. THE ST. JUDE MEDICAL THE EPIC AND ATLAS+ HF CRT-D SYSTEMS ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS. IN PATIENTS INDICATED FOR AN ICD, THE EPIC AND ATLAS+ HF CRT-D SYSTEMS ARE ALSO INTENDED:1) TO PROVIDE A REDUCTION OF THE SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA FUNCTIONAL CLASS III OR IV) IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL MEDICAL THERAPY (AS DEFINED IN THE CLINICAL TRIALS SECTION) AND HAVE A LEFT VENTRICULAR EJECTION FRACTION LESS THAN OR EQUAL TO 35% AND A PROLONGED QRS DURATION 2) TO MAINTAIN SYNCHRONY OF THE LEFT AND RIGHT VENTRICLES IN PATIENTS WHO HAVE UNDERGONE AN AV NODAL ABLATION FOR CHRONIC (PERMANENT) ATRIAL FIBRILLATION AND HAVE NYHA CLASS II OR III HEART FAILURE.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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