CDRH New Update

CDRHNew

Date: March 9, 2017

The following new items were added to the CDRH web pages on March 8, 2017. Previous CDRH New Items can be found on the CDRHNew Page.

• FDA concern over experimental procedures that use balloon angioplasty devices to treat autonomic dysfunction: FDA safety communication
• Class I Medical Device Recall: Physio-Control Inc. Recalls LIFEPAK 1000 Defibrillator Due to an Electrical Issue Which May Cause the Device to Shut Down Unexpectedly