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December 3, 2012
14:43 EDTABMDAbiomed may have to obtain stringent approval for Impella, says Piper
Piper Jaffray predicts that Abiomed could be forced to obtain a PMA, or pre-market approval, for its Impella device. Pre-market approvals are the most stringent type of device marketing application required by the FDA, according to the agency's website. The firm thinks the company will have to conduct a series of new studies, but it maintains an Overweight rating on the stock, citing valuation. However, the firm expects the shares to remain range-bound in the near-term.
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June 29, 2015
12:14 EDTABMDAbiomed says DOJ closes investigation into Impella 2.5
Abiomed announced that it has received confirmation from the United States Department of Justice that it has closed its investigation into the company’s marketing of the Impella 2.5 device without taking enforcement action. “We are pleased that the Department of Justice has chosen to close its investigation without pursuing any further action and that this matter is now behind us. We have always remained steadfast in our integrity and our commitment to putting our patients first,” said Abiomed CEO Michael Minogue.

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