DevicePMAs@therightstef:P910077_S037 JSONTXT 11 Projects

Approval for the ventak prizm 2 vr/dr models 1860/1861, ventak prizm vr/dr models 1850/1851/1855/1856, ventak prizm vr/dr he models 1852/1853, ventak mini iv models 1790/1793/1796 and ventak mini iii he model 1789. These devices are indicated in patients who have had spontaneous and/or inducible life-threatening ventricular arrhythmias and those who are at high risk for developing such arrhythmias. In addition, these devices are indicated for prophylactic treatment of patients with a prior myocardial infarction and an ejection fraction (ef) <=30% (as defined in the clinical study section).