Zdrowie i gospodarka · 20.05.2021
Peripheral Vascular Atherectomy Devices-Premarket Notification Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Peripheral Vascular Atherectomy Devices--Premarket Notification Submissions.'' This guidance provides updated recommendations for premarket submissions for a new or modified peripheral vascular atherectomy device.