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News Breaks
December 6, 2012
19:02 EDTABMDAbiomed's Impella retains Class III status by the FDA
Abiomed announced that the 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.
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