Date: August 19, 2016
The following new items were added to the CDRH web pages on August 18, 2016. Previous CDRH New Items can be found on theCDRHNew Page.
- Consumer Information on: Edwards SAPIEN 3 Transcatheter Heart Valve - P140031S010
- Consumer Information on: Edwards SAPIEN XT Transcatheter Heart Valve - P130009S057
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150029 added)
- Consumer Information on: iPro2 Continuous Glucose Monitoring System - P150029
- Transcripts posted for July 21-22, 2016 Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee meeting
- Consumer Information on: VENTANA PD-L1(SP142) Assay - P160002