CDRH New Update

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.govon August 16, 2019. To view listings for other dates, see CDRH New - News and Updates.

Consumer Information on: Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut PRO System - P130021/S058 Consumer Information on: Edwards SAPIEN 3 Transcatheter Heart Valve System and Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System - P140031/S085 Consumer Information on: The Tether™ - Vertebral Body Tethering System - H190005 Consumer Information on: BAROSTIM NEO System - P180050