Abiomed wins 510(k) clearance from FDA for Impella 5.0 and Impella LD heart pumps
April 23, 2009 by MassDevice staff
Danvers cardiac device maker gets the nod from the federal Food & Drug Administration for its latest heart pumps to hit the market.
Abiomed Inc.'s latest heart pump models got the nod to hit the market from the federal Food & Drug Administration.
The federal watchdog agency granted 510(k) approval for the Danvers-based heart pump maker's Impella 5.0 and Impella LD devices.
That means the minimally-invasive catheter-based pumps are cleared to provide circulatory support for up to six hours, easing the burden on patients' hearts during serious cardiac events.
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