CDRH New Update

CDRHNew

Date: March 4, 2016

The following new items were added to the CDRH web pages on March 3, 2016. Previous CDRH New Items can be found on theCDRHNew Page.

• Summary Information for: Closer Vascular Sealing System (VSS)
• Class I Medical Device Recall: Dräger Evita V500 and Babylog VN500 Ventilators - Recall Expanded to Include Optional PS500 Batteries with New Power Supply Firmware
• Federal Register: Effective Date of Requirement for Premarket Approval for Blood Lancets
• Summary Information for: FENIX™ Continence Restoration System
• Federal Register: General and Plastic Surgery Devices; Reclassification of Blood Lancets
• Summary Information for: PD-L1 IHC 28-8 pharmDx