Approval Order Statement
Approval application (pma) for the res-q acd (arrythmia control device) epicardial patch and non-thoracotomy lead (ntl) systems which consist of the following: model 101-01 & 101-01r res-q implantable arrhythmia control device; model 531-30 rx2000 graphics program module to be used with intermedics commercially available model 522-06 rx2000 graphics programmer; models 497-05, 497-06, and 497-09 right ventricular (rv) defibrillation/pacing leads; model 497-15 subcutaneous patch lead; model 497-16 superior vena cava (svc) leads; models 497-01, 497-02, 497-11, and 497-12 epicardial patch leads; models a67 and l67 commercially available cpi epicardial patch leads; model 370-01 adapter; model 370-21 y-adapter; model 370-04 test box; models 370-03 and 370-23 patient cables; model 370-05 test load; model 370-02 accessory kit; model 370-10 lead caps; and models 370-11, 370-12, 370-13, 370-14, 370-15,370-16, 370-48, and 370-49 stylets. This device is indicated for use in patients who are at high 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 a loss of consciousness) due to a ventricular tachyarrhythmia, or (2) recurrent, poorly tolerated sustained ventricular tachycardia (vt). |
