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Abiomed shares sink as FDA votes to keep Impella pump at highest risk level

December 7, 2012 by MassDevice staff

The FDA's Circulatory System Devices Panel votes to keep Abiomed's Impella heart pump at a Class III risk level, meaning the devices will continue to pass through the premarket review process.

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Abiomed (NSDQ:ABMD) shares slid 7% on Wall Street after the Danvers, Mass.-based cardiac devices maker lost a bid to have its star Impella heart pumps shifted to a lower FDA review risk category.

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News Well, 510(k), Cardiac Assist Devices, Food & Drug Administration (FDA), Pre-Market Approval (PMA), Regulatory/Compliance
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