CDRH New Update

The following new items were added to the CDRH web pages on July 26, 2018. Previous CDRH Newitems can be found on the CDRH New webpage. Consumer Information on: Freestyle Libre 14 Day Flash Glucose Monitoring System - P160030/S017 Peripheral Vascular Atherectomy Devices - Premarket Notification [510(k)] Submissions - Draft Guidance for Industry and Food and Drug Administration Staff Mammography Facility Adverse Event and Action Report – July 26, 2018: Palm Beach Broward Medical Imaging Center  Federal Register: Peripheral Vascular Atherectomy Devices--Premarket Notification Submissions