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Class II devices (e.g., cardiac pressure monitors, powered surgical instruments) are those for which general controls alone are insufficient to assure safety and (continued...) In addition to mandatory controls, the FFDCA contains various discretionary provisions that apply to devices under certain circumstances

Bill Condon Production (role)CompanyProject details Production (role): HEARTSTOPPERCompany: NetflixProject details: Dir

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I dont think theres anything wrong with that, but if the kids want it theyre still going to obtain it just makes it a little bit harder for them," said Susan Porzucek