AbioMed was issued a warning letter from the FDA for reason “the Impella Connect System device is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g).” More specifically, “though some functions of the Impella Connect System may be Non-Device-MDDS, the case tile displays color coded to alarm state and email notifications of alarms that are described in your response, 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.”
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