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Company Pediatric Advisory Committee H080005 Elana Inc. / Elana Inc / Spectranetics / / Country United States / / Event FDA Phase / Product Release / / Facility Name hospital Number / / IndustryTerm medical devices/equipment / postmarket medical device / search criteria / literature search / recent literature search / / MedicalCondition ataxia / strokes / Non-fatal stroke / total non-fatal stroke / aphasia / tumors / aneurysm / ACA aneurysms / complex aneurysms / ischemic stroke / posterior cerebral artery aneurysm / non-fatal strokes / stroke / aneurysms / hemiplegia / giant aneurysm / skull base tumor / hemiparesis / large calcified paraclinoid carotid aneurysm / cerebral aneurysms / / MedicalTreatment catheter / surgeries / Bypass / bypass surgeries / vascular surgery / surgery / / Organization Center for Devices and Radiological Health / FDA / / Person Necessaryper / Location / / Position Executive / treating physician / scrub nurse / patient population Name treating physician / check physician / / Product Elana Surgical KitHUD / H080005 / Elana / / Technology Laser / /
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FDA Executive Summary Prepared for the September 23, 2014 meeting of the Pediatric Advisory Committee H080005