The agency expanded its previous premarket approvals for the catheter-based Impella 5.5 and CP pumps developed by Abiomed, for children weighing at least 30 kilograms and 52 kilograms for each ...

A spokesperson for Johnson & Johnson - which acquired Abiomed in 2022 - told Reuters: "This notification is not a device removal and Impella heart pumps remain on the market and available for ...