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    Drug means any substance or preparation except soaps intended for external or internal use in the cure mitigation treatment remedy or prevention of disease or ailment in man or any other animal and any substance or preparation intended to affect the structure or function of the body of man or any other animal not including food but including medicinal or quasi medicinal preparations

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    a an adverse event is associated with a medical device happened and in such that if it occurred again it might lead to death or serious deterioration in health or b testing examination of the medical device information supplied with the medical device

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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