DevicePMAs@therightstef:P900061_S047 JSONTXT 11 Projects

Approval for modifications to the connector modules and connector assembly. The device, as modified, will be marketed under the trade name gem vr models 7227 b/d/e/cx and is indicated for use in patients who are at risk of sudden death due to ventricular arrhythmias and have experienced one of the following situations: 1) survival of at least one episode of a cardiac arrest (manifested by loss of consciousness) due to a ventricular tachyarrhythmia 2) recurrent, poorly tolerated, sustained ventricular tachycardia.