DevicePMAs@therightstef:P980016_S389 JSONTXT 11 Projects

Approval for clarifications to the indications for use statements related to the optivol feature and other modifications to the device labeling. the devices are indicated as follows: dual chamber icdsthe <device name> dr system is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. In addition, the device is indicated for use in the above patients with atrialtachyarrhythmias, or those patients who are at significant risk of developing atrial tachyarrhythmias. Notes: 1) the use of the device has not been demonstrated to decrease the morbidity related to atrial tachyarrhythmias. 2) the effectiveness of high-frequency burst pacing (atrial 50 hz burst therapy) in terminating device classified atrial tachycardia (at) was found to be 17%, and in terminating device classified atrial fibrillation (af) was found to be 16.8%, in the vt/at patient population studied. 3) the effectiveness of high-frequency burst pacing (atrial 50 hz burst therapy) in terminating device classified atrial tachycardia (at) was found to be 11.7%, and in terminating device classified atrial fibrillation (af) was found to 18.2% in the af-only patient population studied. single chamber icds: the <device name> vr system is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.