Date: November 17, 2016
The following new items were added to the CDRH web pages on November 16, 2016. Previous CDRH New Items can be found on the CDRHNew Page.
- 24 HourSummary posted for November 9, 2016 Microbiology Devices Panel of the Medical Devices Advisory Committee
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150049 added)
- Class I Medical Device Recall: HeartWare Recalls Ventricular Assist Device Controllers Due to Loose Connector Ports
- Class I Medical Device Recall: HeartWare Recalls Ventricular Assist Device Pumps Due to Contamination Causing Electrical Issues