CDRH New Update

CDRHNew

Date: March 16, 2016

The following new items were added to the CDRH web pages on March 15, 2016. Previous CDRH New Items can be found on theCDRHNew Page.

• Class I Medical Device Recall: Abbott Vascular Recalls MitraClip Clip Delivery System Due to Issue with Delivery System Deployment Process
• Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Submission of Medical Device Registration and Listing
• Check the CDRH Customer Service Score
• FDA Medical Device 2015 Quality System Data - Analysis of 2015 Inspection Observations and Warning Letter Cites
• Summary Information for: GORE® EXCLUDER® Iliac Branch Endoprosthesis
• Olympus Validates Updated Reprocessing Instructions for Duodenoscope Models TJF-160F and TJF-160VF: FDA Safety Communication
• Presentations posted for March 15, 2016 Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting
• Summary Information for: SAPIEN XT Transcatheter Heart Valve and Accessories