CDRHNew - News and Updates

CDRHNew - News and Updates

The following new items were added to the CDRH web pages on March 12, 2018. Previous CDRH New items can be found on the CDRH New webpage. Neurovascular Embolization Coils and the Potential for Increased Image Artifact When Using Magnetic Resonance Angiography for Follow-Up - Letter to Health Care Providers Consumer Information on: PulseRider Aneurysm Neck Reconstruction Device ("PulseRider") - H160002 Consumer Information on: LIFEPAK CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator, and CHARGE-PAK® Battery Charger - P160012 Consumer Information on: MiniMed 630G System with SmartGuard - P150001/S021 Consumer Information on: MiniMed 670G System - P160017/S017 Federal Register: Transfer of a Premarket Notification