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Company Covidien / ACom / / Currency pence / / Event FDA Phase / / IndustryTerm flow diversion technology / neurointerventional medical devices / aneurysm treatment technology / assessment tools / follow-up imaging / / MedicalCondition dissecting aneurysms / anterior choroidal aneurysms / particular aneurysms / uses aneurysm / giant wide-neck intracranial aneurysms / large aneurysms / Aneurysm / seizures / berry aneurysms / Unruptured Intracranial Aneurysm / intracranial hemorrhage / basilar apex aneurysms / posterior communicating artery aneurysms / superior hypophyseal artery aneurysms / novel interventional aneurysm / small and medium aneurysms / subarachnoid hemorrhage / small aneurysms / Such aneurysms / PICA / ICA termination aneurysms / previously ruptured aneurysms / injury / Aneurysms Aneurysms / Unruptured Cerebral Aneurysms / clipped aneurysms / illness / posterior aneurysms / intracranial saccular aneurysms / total aneurysms / large and giant aneurysms / angiographically confirmed aneurysms / Treatment Approaches Intracranial aneurysms / Failed Aneurysms / intracerebral aneurysm / fusiform aneurysms / anterior aneurysms / otherwise untreatable aneurysms / cerebral aneurysm / giant aneurysms / larger aneurysms / smaller aneurysms / stroke / pseudoaneurysm / Aneurysms / Rupture rate Aneurysm / intracranial / saccular aneurysms / Treatment Methods While aneurysm / ruptured aneurysm / intracranial aneurysms / saccular aneurysms / wide neck aneurysms / cavernous ICA aneurysms / diagnosed aneurysms / ophthalmic artery aneurysms / cerebral aneurysms / immediate aneurysm / / MedicalTreatment brain surgery / open surgery / surgical treatment / surgery / catheter / / Organization FDA / / Position Aneurysm Executive / strong Executive / Executive / Surgical Clipping Executive / / Product H020002 / H130005 / H060001 / / Technology flow diversion technology / aneurysm treatment technology / /
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FDA Executive Summary Prepared for the April 17, 2015 meeting of the Neurological Devices Panel Meeting to Discuss Clinical Study Design and Evaluation of Clinical Study Data for the Treatment of Aneurysm