www.fdanews.com/articles/175870-abiomed-fda-reach-agreement-on-impella-indications
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Abiomed, FDA Reach Agreement on Impella Indications
March 23, 2016
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