Stryker Neurovascular Neuroform Atlas Stent System - HSA Registration DE0501646
Access comprehensive regulatory information for Stryker Neurovascular Neuroform Atlas Stent System in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0501646 and owned by Stryker Neurovascular. The device was registered on May 17, 2018.
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The Neuroform Atlas Stent System is indicated for use with neurovascular embolic coils in patients who are ≥ 18 years of age for the treatment of wide neck, intracranial, saccular aneurysms arising from a parent vessel with a diameter of ≥ 2 mm and ≤ 4.5 mm that are not amenable to treatment with surgical clipping. Wide neck aneurysms are defined as having a neck ≥ 4mm or a dome-to-neck ratio of < 2. For M003UZASXXXXX: The Neuroform Atlas® Stent System is indicated for use with neurovascular embolization coils in the anterior and posterior circulation of the neurovasculature for the endovascular treatment of patients ≥ 18 years of age with saccular wide-necked (neck width ≥ 4 mm or a dome-to-neck ratio of < 2) intracranial aneurysms arising from a parent vessel with a diameter of ≥ 2.0 mm and ≤ 4.5 mm.