Date: June 6, 2017
The following new items were added to the CDRH web pages on June 5, 2017. Previous items can be found on the CDRHNew Page.
- Class I Medical Device Recall: Magellan Diagnostics Inc. Expands Recall for LeadCare Testing Systems Due to Inaccurate Test Results
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN160043 added)
- Edwards SAPIEN 3 Transcatheter Heart Valve - P140031/S028