DANVERS, Mass.--(BUSINESS WIRE)--Abiomed, Inc. (NASDAQ: ABMD) today announced it recently received a written response from the U.S. Food and Drug Administration (FDA) outlining four areas of concern for which they requested additional information related to the company’s submission for 510(k) clearance of the Impella 2.5.
Two of the questions requested clarification and additional information related to labeling within the 510(k) submission. A third question requested additional information related to bench-testing of the device. A fourth question requested that the company provide an updated clinical review of the global experience with the Impella 2.5 since the original 510(k) submission, including up to date information from the U.S. safety pilot clinical trial for the Impella 2.5. The company plans to respond to this recent request for information.
