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    Cerebral Protection System a prescription device under 21 CFR Part 801 109 that is indicated for the following The Sentinel Cerebral Protection System is indicated for use as an embolic protection device to capture and remove thrombus/debris while performing transcatheter aortic valve replacement procedures

  • A History of Medical Device Regulation Oversight in the

    In the 1960s and 1970s Congress responded to the public s desire for more oversight over medical devices by passing the Medical Device Amendments to the Federal Food Drug

  • Hidden Truth The Perils and Protection of Off Label Drug

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