Abiomed (ABMD) Halted Ahead of FDA Meeting on Blood Pumps

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Abiomed (ABMD) Gets Positive Class III Status Vote for Impella

December 7, 2012 7:06 AM EST

Abiomed, Inc. (Nasdaq: ABMD) announced that the U.S. Food and Drug Administration's (FDA) Circulatory System Devices Panel voted to retain Class III status for the temporary ventricular support devices within the non-roller type cardiopulmonary bypass blood pumps category, which includes Impella®. The 515i Reclassification Panel's confirmation of this category of device as Class III devices is consistent with both the current Class III classification for... More