(B) Exception.--The term does not include a medical device that is surgically implanted, or the replacement of such device.
bˈiː ɛksˈɛpʃən.ðə tˈɜːm dʌznˌɑːt ɪŋklˈuːd ɐ mˈɛdɪkəl dɪvˈaɪs ðæt ɪz sˈɜːdʒɪkli ɪmplˈæntᵻd, ɔːɹ ðə ɹᵻplˈeɪsmənt ʌv sˈʌtʃ dɪvˈaɪs.