Abiomed (ABMD) Release: FDA 515i Reclassification Panel Recommends Class III Status for Temporary Ventricular Support Devices in the Non-Roller Type Cardiopulmonary Bypass Blood Pumps Category
12/7/2012 9:38:48 AM
DANVERS, Mass., Dec. 6, 2012 (GLOBE NEWSWIRE) -- Abiomed, Inc. (Nasdaq:ABMD), a leading provider of breakthrough heart support technologies, today 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 these device types and as recommended in the FDA's briefing documents, released on December 3, 2012.
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