Abiomed
Abiomed Receives FDA 510k Clearance for ImpellaŽ 5.0 and ImpellaŽ LD
Published in Physician Law Weekly, May 13th, 2009
Abiomed, Inc. (NASDAQ: ABMD), a leading provider of break-through heart support technologies enabling safer revascularization, heart recovery and cost-effective patient care, announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its ImpellaŽ 5.0 and ImpellaŽ LD Circulatory Support Devices. This 510(k) clearance designates Impella 5.0 and Impella LD to provide circulatory support for periods of up to six hours.
Similar to the Impella 2.5, which received 510(k) clearance on June 2, 2008 for partial circulatory support for periods of up to six hours, the Impella 5.0 and Impella LD devices are minimally invasive catheter-based...
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Source: Physician Law Weekly (2009-05-13)
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