; (ii) deemed to be approved for an additional payment under section 1886(d)(5)(K); (iii) deemed to be approved for pass-through payment under section 1833(t)(6) and section 1833(i); and (iv) insofar as such breakthrough device may be furnished in a setting for which payment is made under an applicable payment system described in subparagraphs (D) through (I) of subsection (c)(4), deemed eligible for an additional payment pursuant to subsection (d)(3) when furnished in a setting for which payment is made under such an applicable payment system during such transitional coverage period. (B) Transitional coverage period defined As used in this section, the term transitional coverage period means, with respect to a breakthrough device, the period that— (i) begins on the date of the approval under section 515 of the Federal Food, Drug, and Cosmetic Act or of the clearance under section 510(k) of such Act, as applicable, of such device by the Secretary for the indication described in subparagraph (A)(ii) or (B) of subsection (a)(1), respectively