FDA warns Cook Medical on unapproved changes to Evolution lead extractor

The FDA sends a warning letter to Cook Medical, accusing the company of making unapproved changes to its Evolution RL lead extraction device.

The FDA last month accused Cook Medical of selling an unapproved device in the U.S., saying changes made to Cook Vascular's Evolution RL cardiac lead extraction device require the medical device company to file a new clearance application with the watchdog agency.

Cook Medical, Food & Drug Administration (FDA)

News Well, Cardiac Rhythm Management, Regulatory/Compliance, Warning Letter

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