Federal Register Proposed rule: FDA is proposing to reclassify two embolization devices to change their names, revise the identification of the devices, and reclassify them from Class III (premarket approval) into Class II (special controls). The vascular embolization device (previously the arterial embolization device) is intended to control hemorrhaging due to aneurysms, certain tumors, and arteriovenous malformations. The neurovascular embolization device (previously the artificial embolization device) is intended to permanently occlude blood flow to cerebral aneurysms and cerebral arteriovenous malformations. These reclassifications are being proposed based on new information. To view this proposed rule, click here.
