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Abiomed, Inc.
Abiomed Receives 510k Clearance from FDA for Impella 2.5 Device
June 20th, 2008
Abiomed, Inc. (NASDAQ: ABMD) announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Impella 2.5 Cardiac Assist Device. This 510(k) clearance allows Abiomed to begin selling the device to the estimated 14,000 interventional cardiologists at approximately 1,700 heart hospitals in the United States. "FDA clearance of the Abiomed Impella 2.5 represents the next step in enabling heart recovery for patients in the U.S. and will likely change the standard of care in the catheterization lab," said Michael R. Minogue, Chairman, Chief Executive Officer and President of Abiomed. "The device seamlessly provides immediate, minimally...
Source: Health Business Week (2008-06-20)
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