Abiomed continues rebound, expects to file Impella PMA this fiscal year

May 6, 2013 by Brad Perriello

Abiomed CEO Michael Minogue says the company expects to file for pre-market approval from the FDA by the end of fiscal 2014, stressing that it's "business as usual" until then.

Abiomed continues rebound, expects to file Impella PMA by end of fiscal year

Abiomed (NSDQ:ABMD) shares continued their rebound today from a plunge begun late last year after news broke of a federal investigation and new FDA requirements for its flagship Impella heart pump.

The Danvers, Mass.-based medical device company's stock soared last week after it released its fiscal 4th-quarter and 2013 results, reporting soaring profits on solid, double-digit sales growth. Shares continued the trend today, rising about 1.5% in mid-morning trading.

In December, an FDA advisory panel recommended that some categories of heart pumps, including the Impella, be required to submit pre-market approval applications to the agency even if they've already been approved via the FDA's 510(k) clearance protocol, continuing the slide for ABMD shares begun when it revealed a federal probe into its marketing of the Impella device.

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