ABIOMED, Inc. (ABMD)

[surf1944]

1:16AM Abiomed: FDA 515i Reclassification Panel recommends Class III Status for Temporary Ventricular Support Devices in the non-roller type cardiopulmonary bypass blood pumps category (ABMD) 12.88 : Co announces 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, 2012. As per the statues of the 515i program, there is no change to the current 510(k) clearance for Impella throughout the remaining steps of the reclassification process for Non-Roller Type Cardiopulmonary Bypass Pumps. Following yesterday's Panel recommendation, the next steps in the 515i process include FDA issuance of a Proposed Final Order, followed by a period of public comment, FDA issuance of a Final Order, and then submission of Pre-Market Approval applications by manufacturers with devices in the category.