DevicePMAs@therightstef:P010031_S232 JSONTXT 11 Projects

Approval for a modification to the indications for use as follows. for the concerto crt-d model c154dwk, consulta crt-d model d224trk, concerto ii crt-d model d274trk, protecta crt-d model d334trg, protecta crt-d model d334trm, protecta xt crt-d model d314trg, protecta xt crt-d model d314trm, and consulta crt-d model d204trm cardiac resynchronization therapy defibrillators (crt-ds) the indications for use are: the crt-d system is indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmiasand for providing cardiac resynchronization therapy in heart failure patients who remain symptomatic despite optimal medical therapy, and meet any of the following classifications: 1) new york heart association (nyha) functional class iii or iv and who have a left ventricular ejection fraction <= 35% and a prolonged qrs duration. 2) left bundle branch block (lbbb) with a qrs duration >= 130 ms, left ventricular ejectionfraction <= 30%, and nyha functional class ii. the system is also indicated for use in patients with atrial tachyarrhythmias, or those patients who are at significant risk for developing atrial tachyarrhythmias. atrial rhythm management features such as atrial rate stabilization (ars), atrial preference pacing (app), and post mode switch overdrive (pmop) are indicated for the suppression of atrial tachyarrhythmias in implantable cardioverter defibrillator (icd)-indicated patients with atrial septal lead placement and an icd indication. for the maximo ii crt-d model d284trk and maximo iicrt-d model d264trm cardiac resynchronization therapy defibrillators (crt-ds) the indications for use are: (for additional information, please see approval order.)