CDRH New Update

CDRHNew

Date: December 23, 2015

The following new items were added to the CDRH web pages on December 22, 2015. Previous CDRH New Items can be found on theCDRHNew Page.

• Summary Information for: Astron Peripheral Self-Expanding Nitinol Stent System
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN130039 added)
• Federal Register: General and Plastic Surgery Devices: Restricted Sale Distribution, and Use of Sunlamp Products
• Summary Information for: Paradigm Real-Time Revel System
• Risk of Eye and Skin Injuries from Hand-held Laser Pointers: FDA Safety Communication
• Federal Register: Sunlamp Products; Proposed Amendment to Performance Standard
• Summary Information for: VISCO-3™