In a warning letter dated Sept. 19 that was made public on Tuesday, the agency slammed Abiomed for classifying certain software functions of its Impella Connect system as "non-device clinical decision support" rather than a medical device.
In a warning letter dated Sept. 19 that was made public on Tuesday, the agency slammed Abiomed for classifying certain software functions of its Impella Connect system as "non-device clinical decision support" rather than a medical device.
