UPDATE: FDA warns doc on CoreValve heart implant trial record-keeping issues

March 1, 2013 by Brad Perriello

A doctor participating in a clinical trial of Medtronic's CoreValve heart implant had "serious violations" of FDA record-keeping rules, prompting a warning letter from the federal watchdog agency.

Medtronic's CoreValve heart implant

UPDATED March 1, 2013, 2 p.m. EST with comment from Medtronic.

Hard on the heels of a regulatory win in Europe for 1 of its heart implants, Medtronic (NYSE:MDT) got some bad news from the FDA regarding another.

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