DevicePMAs@therightstef:P060001_S000 JSONTXT 11 Projects

Approval for the protege gps and protege rx carotid stent systems. this device is indicated for used in conjunction with ev3 embolic protection devices, are indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet the following criteria: 1) patients with carotid artery stenosis (>= 50% for symptomatic patients by ultrasound or angiography or >= 80% for asymptomatic patients by ultrasound or angiography) of the common or internal carotid artery, and2) patients must have a reference vessel diameter within the range of 4.5 mm and 9.5 mm at the target lesion.