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Under this alternative pathway, devices that are granted an FDA Breakthrough Device designation are not evaluated in terms of the current substantial clinical improvement criterion at 419.66(c)(2) for the purposes of determining device pass-through payment status, but do need to meet the other requirements for pass-through payment status in our regulation at 419.66

each compound is supplied separately as lyophilised material strictly for in-vitro laboratory research use only.

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BMI 30 : Must also have heart failure, uncontrolled high blood pressure, or chronic kidney disease