Guidance on Vascular and Neurovascular Embolization Devices
02/25/2004
Federal Register Notice: FDA is making available a draft guidance for industry and FDA staff entitled Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices. It was developed as a special control to support the reclassification of the vascular embolization device and the neurovascular embolization device from Class III (premarket approval) into Class II (special controls). To download this guidance, click here. To view this notice, click here.
