CDRH New Update

The following new items were added to the CDRH web pages on March 6, 2018. Previous CDRH Newitems can be found on the CDRH New webpage.

• February 2018 PMA Approval List
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN170046 added)
• Press Release: FDA expands approval of replacement heart valve, smallest mechanical valve size approved in the world
• Federal Register: General and Plastic Surgery Devices; Classification of the Extracorporeal Shock Wave Device for Treatment of Chronic Wounds
• Federal Register: Reclassification Petitions for Medical Devices