Three of Four FDA Questions on Abiomed’s 510(k) Submission Resolved
January 25, 2008 - The FDA informed Abiomed Inc. that the first three areas of concern regarding submission for 510(k) clearance of its Impella 2.5 circulatory support device have been resolved, plus the clinical data provided by company has been accepted by the FDA and the labeling has been agreed upon.
The remaining request for information involves comparative bench testing relative to one of the predicate devices proposed. While bench testing is usually conducted to predict clinical results, in the case of the Impella 2.5 510(k) submission, the clinical results have been accepted and the bench testing is requested as another data set, according to the manufacturer.
“We are pleased with the most recent update from the FDA and will work diligently on a thorough and expedient response to this request for additional information,” stated Michael R. Minogue, Chairman, President and CEO of Abiomed. “As we have stated since our original submission, there are no guarantees but we remain confident that we will receive 510(k) clearance for the Impella 2.5.”
For additional information: www.abiomed.com