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Device | EPIC AND ATLAS+ HF CRT-D SYSTEMS |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P030054 |
Supplement Number | S010 |
Date Received | 06/06/2005 |
Decision Date | 11/18/2005 |
Product Code |
NIK |
Docket Number | 05M-0492 |
Notice Date | 12/19/2005 |
Advisory Committee |
Cardiovascular |
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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 Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |