Abiomed Gets Warning Letter for Failure to Get Premarket Approval for Impella System

Abiomed received a warning letter for its Impella Connect System for failing to have an approved application for premarket approval or an investigational device exemption, according to the FDA’s warning letter.

The FDA letter acknowledged that, in response to the FDA’s March 1 to April 13 inspection of Abiomed’s Danvers, Mass., location, the firm refuted the FDA’s position on the nature of its device.

According to the warning letter, Abiomed stated that the clinical decision support functions of the Impella Connect System provide “a concise and user-friendly view of active AIC [automated Impella controller] case status” and “concise notifications,” and therefore are non-device clinical decision support software functions.”

“We disagree,” the FDA wrote, explaining that the color coded displays and email notifications of alarms “provide patient-specific medical information to detect a life-threatening condition and display time-critical alarms intended to notify a health-care provider, which are functions that meet the definition of a device under the Act and therefore require premarket authorization.”

Read the warning letter here.

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