DevicePMAs@therightstef:P010030_S004 JSONTXT 11 Projects

Approval for minor software, hardware, and labeling changes. The device, as modified, will be marketed under the trade name lifevest (wcd 3000) wearable defibrillator and is indicated for adult patients who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.

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