DevicePMAs@therightstef:P970024_S001 JSONTXT 11 Projects

Approval for the Lyra(TM) ICD System (Models 2020, 2021, and 2022), Model 6200 Programmer Software, Smart Wand Programming Head Model 3009, Angepass(TM) RV Defibrillation Lead System (Model 4040, 4041, and 4042), and AngePass(TM) SVC Defibrillation Lead System (Models 4080, 4081, and 4082). The devices as modified will be marketed under the trade names Lyra(TM) and AngePass(TM), and are 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 cardiac arrest (manifested by loss of consciousness) due to a ventricular tachyarrhythmia; and 2)Recurrent, poorly tolerated, sustained ventricular tachyarrhythmia.