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Supreme Court Will Hear Case Against Medtronic

Bloomberg News reports that the Supreme Court

(This applies to PMA products; suits have been allowed to proceed against 510(k) and pre-1976 products, which are less rigorously reviewed.) The case involves a patient who had a Medtronic catheter burst inside of him during an angioplasty, and then required bypass surgery. Medtronic says the doctor was using the catheter off-label.

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