The following new items were added to the CDRH web pages on March 14, 2019. Previous CDRH Newitems can be found on the CDRH New webpage.
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN170044 added)
- Webinar - Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) Final Guidance - April 23, 2019
- Consumer Information on: Barricaid® Anular Closure Device (ACD) - P160050
- Consumer Information on: MitraClip NT Clip Delivery System and MitraClip NTR/XTR Clip Delivery System - P100009/S028
- Press Release: FDA approves new indication for valve repair device to treat certain heart failure patients with mitral regurgitation
- Press Release: FDA allows marketing of new device to help treat carbon monoxide poisoning
- Federal Register: Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices)
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