Medtronic, Inc., St. Jude Medical Recalls Illustrate Why PMA Modifications Don’t Work

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A new editorial in the Annals of Internal Medicine criticizes the premarket approval modification process, through which both Medtronic and St. Jude Medical released high-risk products that were later recalled. A new editorial in the Annals of Internal Medicine singled out devices from medtech giants Medtronic (NYSE:MDT) and St. Jude Medical (NYSE:STJ) as examples of how flaws in the FDA’s review process may allow faulty devices onto the market.

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