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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namepulse generator, permanent, implantable
PMA NumberP890003
Supplement NumberS309
Date Received04/11/2014
Decision Date07/03/2014
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Clinical Trials NCT00980057
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
Approval for the viva/brava quadripolar cardiac resynchronization therapy defibrillator (crt-d) devices and is indicated for patients who require ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life- threatening ventricular arrhythmias, for use in patients with atrial tachyarrhythmias, or those patients who are at significant risk for developing atrial tachyarrhythmias and for providing cardiac resynchronization therapy in heart failure patients on stable, optimal heart failure medical therapy if indicated, and meet any of the classifications provided in the labeling.
Approval Order Approval Order