Abiomed plans to file a premarket approval application with the FDA for its Impella heart pump at the close of fiscal year 2014. With the trove of data showing real-world use of the device, which already has 510(k) clearance, CEO Michael Minogue believes Abiomed could get the PMA without having to conduct another trial. "We'd like to be one of the first success stories in the industry that's converted from a 510(k) through the 515 process to PMA," he said.
Abiomed readies PMA application for Impella heart pump
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