CDRH New Update

The following new items were added to the CDRH web pages on June 1, 2018. Previous CDRH Newitems can be found on the CDRH New webpage.

• Consumer Information on: Restylane Lyft with Lidocaine - P040024/S099
• Class I Medical Device Recall: Medtronic HeartWare HVAD System Recalled Due to Unintended Intermittent Electrical Disconnection between The Power Source and The Controller
• Presentation and Transcript added to Webinar - Final Guidances on Next Generation Sequencing-based Tests - May 24, 2018
• Federal Register: Exemptions From Premarket Notification: Class II Devices
• Federal Register: Reclassification of Medical Image Analyzer