DevicePMAs@therightstef:P170013_S000 / 180-183 JSONTXT

Approval for the Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. This device is indicated for use with neurovascular embolization coils in patients >= 18 years of age for the treatment of wide-neck (neck width >= 4 mm or dome to neck ratio < 2) saccular intracranial aneurysms arising from a parent vessel with a diameter >= 2.0 mm and <= 4.5 mm.

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PMA_MER (1)