2 results
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28ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Elana Catheter Sizer 2.0*** The Elana Catheter Sizer 2.0 is designed to aid the surgeon to assess the bypass graft of the ELANA technique.
FDA Enforcement
Class II
·Terminated·Elana, Inc.·April 24, 2013
Elana Surgical KitHUD The Elana Surgical KitHUD, when connected to the Spectranetics Xenon-Chloride Laser Model CVX-300, is indicated for creating arteriotomies during an intracranial vascular bypass procedure in patients 13 years of age or older with an aneurysm or a skull base tumor affecting a large [> 2.5 mm], intracranial artery that failed balloon test occlusion, cannot be sacrificed, or cannot be treated with conventional means due to local anatomy or complexity
FDA Enforcement
Class II
·Terminated·Elana, Inc.·December 14, 2016