CDRH New Update

CDRHNew

Date: May 24, 2017

The following new items were added to the CDRH web pages on May 23, 2017. Previous items can be found on the CDRHNew Page.

• Class I Medical Device Recall: Abbott-Thoratec Recalls HeartMate II LVAS Pocket System Controller Due to Risk of Patient Injury and/or Death during Backup Controller Exchange
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN170019 added)
• 24 Hour Summary posted for the May 17, 2017 Gastroenterology-Urology Devices Panel of the Medical Devices Advisory Committee