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Home » Abiomed, FDA Reach Agreement on Impella Indications
Abiomed, FDA Reach Agreement on Impella Indications
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Abiomed has come to an agreement with the FDA on indications for the company’s Impella CP, 2.5, 5.0 and LD devices and doesn’t expect a need for review from an FDA advisory panel, the company said.
According to a Securities and Exchange Commission filing, based on discussion between Abiomed and the agency and available information, the company believes a panel review prior to PMA approval is no longer necessary.
The devices are indicated for use in patients suffering from cardiogenic shock following acute myocardial infarction or cardiac surgery. — Anisa Jibrell
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