DevicePMAs@therightstef:P020050_S019 JSON TXT

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PMA_MER

updated_tagging_age_PMA_annotations

{"project":"updated_tagging_age_PMA_annotations","denotations":[{"id":"T2","span":{"begin":845,"end":869},"obj":"age_range"},{"id":"T4","span":{"begin":848,"end":853},"obj":"age_start_unit"},{"id":"T5","span":{"begin":845,"end":847},"obj":"age_start"},{"id":"T6","span":{"begin":864,"end":869},"obj":"age_end"}],"text":"Approval to expand the approval of the topolyzer vario to include its use as a diagnostic device supporting the wavelight excimer lasers in performing t-cat lasik. the device, as modified, will be marketed under the trade name allegro topolyzer vario and is indicated for the wavelight allegretto wave eye-q excimer laser system used in conjunction with the wavelight allegro topolyzer (topographer) or allegro topolyzer vario (topographer) and t-cat treatment planning software is indicated for performing topography-guided laser assisted in situ keratomileusis (topo-guided (t-cat) lasik):1) for the reduction or elimination of up to -9.00 diopters (d) of spherical equivalent myopia or myopia with astigmatism, with up to -8.00 d of spherical component and up to -3.00 d of astigmatic component at the spectacle plane; 2) in patients who are 18 years of age or older; and3) in patients with documentation of a stable manifest refraction defined as 0.50 d or less of preoperative spherical equivalent shift over one year prior to surgery."}

consensus_PMA_Age_Indications

{"project":"consensus_PMA_Age_Indications","denotations":[{"id":"T2","span":{"begin":845,"end":869},"obj":"age_range"},{"id":"T5","span":{"begin":845,"end":847},"obj":"age_start"},{"id":"T4","span":{"begin":848,"end":853},"obj":"age_start_unit"},{"id":"T6","span":{"begin":864,"end":869},"obj":"age_end"}],"text":"Approval to expand the approval of the topolyzer vario to include its use as a diagnostic device supporting the wavelight excimer lasers in performing t-cat lasik. the device, as modified, will be marketed under the trade name allegro topolyzer vario and is indicated for the wavelight allegretto wave eye-q excimer laser system used in conjunction with the wavelight allegro topolyzer (topographer) or allegro topolyzer vario (topographer) and t-cat treatment planning software is indicated for performing topography-guided laser assisted in situ keratomileusis (topo-guided (t-cat) lasik):1) for the reduction or elimination of up to -9.00 diopters (d) of spherical equivalent myopia or myopia with astigmatism, with up to -8.00 d of spherical component and up to -3.00 d of astigmatic component at the spectacle plane; 2) in patients who are 18 years of age or older; and3) in patients with documentation of a stable manifest refraction defined as 0.50 d or less of preoperative spherical equivalent shift over one year prior to surgery."}

Age_blah

{"project":"Age_blah","denotations":[{"id":"T1","span":{"begin":845,"end":847},"obj":"age_start"},{"id":"T2","span":{"begin":848,"end":853},"obj":"age_start_unit"},{"id":"T3","span":{"begin":864,"end":869},"obj":"age_end"},{"id":"T4","span":{"begin":845,"end":869},"obj":"age_range"}],"text":"Approval to expand the approval of the topolyzer vario to include its use as a diagnostic device supporting the wavelight excimer lasers in performing t-cat lasik. the device, as modified, will be marketed under the trade name allegro topolyzer vario and is indicated for the wavelight allegretto wave eye-q excimer laser system used in conjunction with the wavelight allegro topolyzer (topographer) or allegro topolyzer vario (topographer) and t-cat treatment planning software is indicated for performing topography-guided laser assisted in situ keratomileusis (topo-guided (t-cat) lasik):1) for the reduction or elimination of up to -9.00 diopters (d) of spherical equivalent myopia or myopia with astigmatism, with up to -8.00 d of spherical component and up to -3.00 d of astigmatic component at the spectacle plane; 2) in patients who are 18 years of age or older; and3) in patients with documentation of a stable manifest refraction defined as 0.50 d or less of preoperative spherical equivalent shift over one year prior to surgery."}

PMA_age_indications

{"project":"PMA_age_indications","denotations":[{"id":"T5","span":{"begin":845,"end":847},"obj":"age_start"},{"id":"T2","span":{"begin":845,"end":869},"obj":"age_range"},{"id":"T4","span":{"begin":848,"end":853},"obj":"age_start_unit"},{"id":"T6","span":{"begin":864,"end":869},"obj":"age_end"}],"text":"Approval to expand the approval of the topolyzer vario to include its use as a diagnostic device supporting the wavelight excimer lasers in performing t-cat lasik. the device, as modified, will be marketed under the trade name allegro topolyzer vario and is indicated for the wavelight allegretto wave eye-q excimer laser system used in conjunction with the wavelight allegro topolyzer (topographer) or allegro topolyzer vario (topographer) and t-cat treatment planning software is indicated for performing topography-guided laser assisted in situ keratomileusis (topo-guided (t-cat) lasik):1) for the reduction or elimination of up to -9.00 diopters (d) of spherical equivalent myopia or myopia with astigmatism, with up to -8.00 d of spherical component and up to -3.00 d of astigmatic component at the spectacle plane; 2) in patients who are 18 years of age or older; and3) in patients with documentation of a stable manifest refraction defined as 0.50 d or less of preoperative spherical equivalent shift over one year prior to surgery."}