CDRH New Update

The following new items were added to the CDRH web pages on December 18, 2017. Previous CDRH New items can be found on the CDRH New webpage. Consumer Information on: Revanesse Ultra - P160042 Consumer Information on: EluNIR® Ridaforolimus Eluting Coronary Stent System - P170008 Federal Register: Obstetrical and Gynecological Devices; Classification of the Fetal Head Elevator Federal Register: Ophthalmic Devices; Classification of the Tear Electrostimulation Device Federal Register: Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices