d389ec27-75b4-4604-9e92-0e874cc9c383UpdatePublished22026-06-122022-10-282026-06-09Not in Commercial Distribution00763000489243PrimaryGS1Axium™ Detachable Coil SystemPC-7-20-3D826110710Micro Therapeutics, Inc.1COIL PC-7-20-3D V12falsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseMR Conditionaltruefalse+1(800)633-8766Corporate.UDI@medtronic.comK20343200060940Neurovascular embolization coilA non-bioabsorbable, implantable device intended to induce a neurovascular thrombosis to treat an intracranial aneurysm and/or neurovascular arteriovenous malformation (AVM); it may also be intended to treat non-neurovascular malformations. It is in the form of a metal [e.g., platinum alloy] or metal/synthetic polymer wire which coils upon deployment within the aneurysm/vasculature; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.trueActiveKRDDevice, Vascular, for Promoting EmbolizationHCGDEVICE, NEUROVASCULAR EMBOLIZATIONStorage Environment TemperatureSpecial Storage Condition, SpecifyStore in dry place, away from sunlight.truefalse