|Trade Name||PHYLAX 06 ICD/ACTIVE HOUSING/REPLACEMENT, MYCROPHYLAX/TMS 1000 TACHYARRHYTHMIA MONITORING SYSTEM|
|Classification Name||implantable cardioverter defibrillator (non-crt)|
|Generic Name||implantable cardioverter defibrillator (non-crt)|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for device hardware and software modifications. The device, as modified, will be marketed under the trade name mycrophylax(plus), phylax xm, and tms 1000(plus) tachyarrhythmia monitoring system. The devices are indicated for use in patients who are at risk of sudden death due to ventriular arrhythmias and have experienced one of the following situations: survival of at least one episode of cardiac arrest (manifested by a loss of consciousness) due to a ventricular tachyarrhythmias; or recurrent poorly tolerated sustained ventricular tachycardia (vt).