date This section, and the amendments made by this section, shall take effect on the date of the enactment of this Act and, unless otherwise specified in this section (or in an amendment made by this section), shall apply to breakthrough devices (as defined in section 1899C(a) of the Social Security Act, as added by subsection (a)), approved or cleared on or after July 1, 2019, or, in the case of a specified breakthrough device (as defined in such section as so added), approved or cleared on or after December 1, 2018.