DevicePMAs@therightstef:P950037_S078 / 0-6 JSONTXT

Approval for introduction of the lumax 540 vr-t dx implantable cardioverter defibrillator (icd), a single lead icd system used in conjunction with the currently approved kainox a+ icd lead. The device, as modified, will be marketed under the trade name lumax 540 vr-t dx icd and is indicated for providing ventricular antitachycardia pacing and ventricular defibrillation, for automated treatment of life threatening ventricular arrhythmias.

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