Issue Date: June 18, 2007
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, Good Clinical Practice (GCP)
Status: Final
Pre-Clinical and Clinical Studies for Neurothrombectomy Devices: Guidance for Industry and FDA Staff
This guidance document describes FDA’s recommendations for pre-clinical and clinical studies that involve neurothrombectomy devices conducted to support premarket submissions for neurothrombectomy devices indicated for ischemic stroke. A neurothrombectomy device is intended to retrieve or destroy blood clots in the cerebral neurovasculature by mechanical (i.e., snare or suction), laser, ultrasound technologies, or combination of technologies.
Download the Guidance Document
