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Bloomberg News reports that the Supreme Court
June 25, 2007
1 Min Read
(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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