Abiomed (NSDQ:ABMD) shares are up sharply this morning on news of an agreement with the FDA on the indication for its Impella 2.5 heart pump, which the company now expects to win pre-market approval in early 2015 without an appearance before an FDA advisory panel.
The federal watchdog agency's Circulatory Devices panel recommended in late 2012 that devices like Abiomed's flagship Impella 2.5 device be subject to the FDA's most stringent PMA protocol. The pump had been allowed on the U.S. market via the FDA's less-stringent 510(k) clearance protocol.
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The federal watchdog agency's Circulatory Devices panel recommended in late 2012 that devices like Abiomed's flagship Impella 2.5 device be subject to the FDA's most stringent PMA protocol. The pump had been allowed on the U.S. market via the FDA's less-stringent 510(k) clearance protocol.
Help employers find you! Check out all the jobs and post your resume.
