April 19, 2017
Warning Letter Alleges Multiple QS Regulation Violations Relating to St. Jude Cardiac Devices
An April 12 FDA Warning Letter issued to Abbott alleging quality system (QS) regulation violations involving St. Jude Medical defibrillators and a wireless home monitor device — sent in the wake of battery supply and cybersecur...
You must be a subscriber to access this information. If you are a subscriber, please login. Not Yet A Subscriber? Click here to register for a free trial or contact Client Services at 800-677-3789 to activate your subscription.