News | January 24, 2008

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

Related Content

Cardiogenic Shock Survival Rates Improve in Three Years Since Impella FDA Approval
News | Ventricular Assist Devices (VAD) | April 05, 2019
Three years ago this week, Abiomed's Impella heart pump received U.S. Food and Drug Administration (FDA) premarket...
HeartMate 3 Pump Shows Superior Outcomes in Advanced Heart Failure
News | Ventricular Assist Devices (VAD) | March 22, 2019
Severely ill patients with advanced heart failure who received the HeartMate 3 left ventricular assist device (LVAD)...
Leviticus Cardio and Jarvik Heart Unveil Wireless Heart Pump System
News | Ventricular Assist Devices (VAD) | February 11, 2019
Heart failure experts at the National Research Center for Cardiac Surgery in Astana, Kazakhstan, recently announced the...
Medtronic Receives FDA Approval for Less-Invasive Heart Pump Implant Procedure
Technology | Ventricular Assist Devices (VAD) | July 17, 2018
Medtronic plc recently received U.S. Food and Drug Administration (FDA) approval for a less-invasive implant approach...
CorWave's Next-generation Neptune LVAD Receives Funding

Image courtesy of CorWave

News | Ventricular Assist Devices (VAD) | July 11, 2018
French-based CorWave announced that its CALYPSO program has received 14 million euros to develop CorWave Neptune, a new...
Abbott Recalls the HeartMate 3 Left Ventricular Assist System, LVAD
News | Ventricular Assist Devices (VAD) | May 23, 2018
Abbott has initiated a Class I recall of the HeartMate 3 Left Ventricular Assist System due to a malfunction in the...
FDA Approves Abiomed Impella CP With SmartAssist and Optical Sensor
Technology | Ventricular Assist Devices (VAD) | April 02, 2018
Abiomed Inc. announced that it received U.S. Food and Drug Administration (FDA) Pre-Market Approval (PMA) for its...
Reduced Device Clotting, Decreased Strokes Seen With HeartMate 3 at Two Years
News | Ventricular Assist Devices (VAD) | March 13, 2018
At two years of follow-up, severely ill patients with advanced heart failure who received a novel heart pump fully...
Medtronic HeartWare HVAD System Approved for Destination Therapy
Technology | Ventricular Assist Devices (VAD) | October 04, 2017
October 4, 2017 — Medtronic received U.S.
Overlay Init