CDRH New Update

The following new items were added to the CDRH web pages on May 18, 2018. Previous CDRH Newitems can be found on the CDRH New webpage. Class I Medical Device Recall: Medtronic Recalls MindFrame Capture LP Revascularization Device Due to Wire Material That May Break or Separate During Use Presentation and Transcript added to User Session - Digital Health Software Precertification (Pre-Cert) Pilot Program - May 10, 2018