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The Food and Drug Administration has announced on its website that medical device maker St. Jude Medical last month recalled a device used in heart surgery because of the risk that it could cause ...
A drug recall removes a prescription or over-the-counter drug from the market. Drug recalls in the United States are made by the FDA or the creators of the drug when certain criteria are met. When a drug recall is made, the drug is removed from the market and potential legal action can be taken depending on the severity of the drug recall. [1]
St. Jude Medical was founded in 1976 to further develop bi-leaflet artificial heart valves, which were originally created in 1972 at the University of Minnesota. [4] [5] St. Jude Medical's bi-leaflet valve was developed in large part by Dr. Demetre Nicoloff of the University of Minnesota and St. Jude Medical employee Don Hanson.
Another piece of bad news has come out for St. Jude Medical (NYS: STJ) regarding an FDA report on defibrillator lead Durata, bringing shares down 12%. In this video, Motley Fool health-care ...
The hits keep on coming for St. Jude Medical . Fresh off earnings that showed the continued decline of its cardiac rhythm management, or CRM, sales, St. Jude took a fresh cardio kick this week ...
FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.
Medical device maker St. Jude Medical announced in a press statement Wednesday that it has enrolled the first patient in a clinical trial of its EnligHTN renal denervation device. The study ...
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