DevicePMAs@therightstef:P030016_S001 JSONTXT

{"project":"PMA_MER","denotations":[{"id":"T1","span":{"begin":0,"end":8},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25425"},{"id":"T2","span":{"begin":56,"end":60},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C12743"},{"id":"T3","span":{"begin":67,"end":73},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C62103"},{"id":"T4","span":{"begin":91,"end":94},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25340"},{"id":"T5","span":{"begin":138,"end":148},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C54657"},{"id":"T6","span":{"begin":186,"end":196},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C48793"},{"id":"T7","span":{"begin":266,"end":271},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C63534"},{"id":"T8","span":{"begin":278,"end":286},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C63806"},{"id":"T9","span":{"begin":298,"end":303},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C63534"},{"id":"T10","span":{"begin":333,"end":342},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C157203"},{"id":"T11","span":{"begin":380,"end":390},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C48793"},{"id":"T12","span":{"begin":404,"end":411},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C61421"},{"id":"T13","span":{"begin":452,"end":457},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C63534"},{"id":"T14","span":{"begin":464,"end":472},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C63806"},{"id":"T15","span":{"begin":484,"end":489},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C63534"},{"id":"T16","span":{"begin":516,"end":524},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25231"},{"id":"T17","span":{"begin":533,"end":538},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25333"},{"id":"T18","span":{"begin":559,"end":566},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C61421"},{"id":"T19","span":{"begin":573,"end":581},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C44473"},{"id":"T20","span":{"begin":591,"end":610},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C12707"},{"id":"T21","span":{"begin":599,"end":610},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C12481"},{"id":"T22","span":{"begin":618,"end":626},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25231"},{"id":"T23","span":{"begin":627,"end":634},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25245"},{"id":"T24","span":{"begin":654,"end":658},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C12743"},{"id":"T25","span":{"begin":665,"end":671},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C30103"},{"id":"T26","span":{"begin":683,"end":690},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C54625"},{"id":"T27","span":{"begin":692,"end":698},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25282"},{"id":"T28","span":{"begin":723,"end":733},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C48793"},{"id":"T29","span":{"begin":738,"end":746},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C63806"},{"id":"T30","span":{"begin":753,"end":757},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C29848"},{"id":"T31","span":{"begin":758,"end":763},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25629"},{"id":"T32","span":{"begin":767,"end":779},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C51982"},{"id":"T33","span":{"begin":820,"end":829},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C126366"},{"id":"T34","span":{"begin":837,"end":846},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25622"}],"text":"Approval for the Visian Toric ICL (Implantable Collamer Lens). The device is indicated for use in patients 21-45 years of age: 1) for the correction of myopic astigmatism with spherical equivalent ranging from -3.0D to less than or equal to -15.0D (in the spectacle plane) with cylinder (spectacle plane) of 1.0D to 4.0D; 2) for the reduction of myopic astigmatism with spherical equivalent ranging from greater than -15.0D to -20.0D (in the spectacle plane) with cylinder (spectacle plane) 1.0D to 4.0D; 3. with an anterior chamber depth (ACD) of 3.00 mm or greater, when measured from the corneal endothelium to the anterior surface of the crystalline lens and a stable refractive history (within 0.5D for both spherical equivalent and cylinder for 1 year prior to implantation); and4) The Visian TICL is intended for placement in the posterior chamber (ciliary sulcus) of the phakic eye."}

{"project":"consensus_PMA_Age_Indications","denotations":[{"id":"T1","span":{"begin":107,"end":118},"obj":"age_range"},{"id":"T7","span":{"begin":107,"end":109},"obj":"age_start"},{"id":"T6","span":{"begin":110,"end":112},"obj":"age_end"},{"id":"T8","span":{"begin":113,"end":118},"obj":"age_end_unit"}],"text":"Approval for the Visian Toric ICL (Implantable Collamer Lens). The device is indicated for use in patients 21-45 years of age: 1) for the correction of myopic astigmatism with spherical equivalent ranging from -3.0D to less than or equal to -15.0D (in the spectacle plane) with cylinder (spectacle plane) of 1.0D to 4.0D; 2) for the reduction of myopic astigmatism with spherical equivalent ranging from greater than -15.0D to -20.0D (in the spectacle plane) with cylinder (spectacle plane) 1.0D to 4.0D; 3. with an anterior chamber depth (ACD) of 3.00 mm or greater, when measured from the corneal endothelium to the anterior surface of the crystalline lens and a stable refractive history (within 0.5D for both spherical equivalent and cylinder for 1 year prior to implantation); and4) The Visian TICL is intended for placement in the posterior chamber (ciliary sulcus) of the phakic eye."}

{"project":"Age_blah","denotations":[{"id":"T1","span":{"begin":107,"end":109},"obj":"age_start"},{"id":"T2","span":{"begin":110,"end":112},"obj":"age_end"},{"id":"T3","span":{"begin":113,"end":118},"obj":"age_end_unit"},{"id":"T4","span":{"begin":107,"end":112},"obj":"age_range"}],"text":"Approval for the Visian Toric ICL (Implantable Collamer Lens). The device is indicated for use in patients 21-45 years of age: 1) for the correction of myopic astigmatism with spherical equivalent ranging from -3.0D to less than or equal to -15.0D (in the spectacle plane) with cylinder (spectacle plane) of 1.0D to 4.0D; 2) for the reduction of myopic astigmatism with spherical equivalent ranging from greater than -15.0D to -20.0D (in the spectacle plane) with cylinder (spectacle plane) 1.0D to 4.0D; 3. with an anterior chamber depth (ACD) of 3.00 mm or greater, when measured from the corneal endothelium to the anterior surface of the crystalline lens and a stable refractive history (within 0.5D for both spherical equivalent and cylinder for 1 year prior to implantation); and4) The Visian TICL is intended for placement in the posterior chamber (ciliary sulcus) of the phakic eye."}

{"project":"Age_blah","denotations":[{"id":"T1","span":{"begin":107,"end":109},"obj":"age_start"},{"id":"T2","span":{"begin":110,"end":112},"obj":"age_end"},{"id":"T3","span":{"begin":113,"end":118},"obj":"age_end_unit"},{"id":"T4","span":{"begin":107,"end":112},"obj":"age_range"}],"text":"Approval for the Visian Toric ICL (Implantable Collamer Lens). The device is indicated for use in patients 21-45 years of age: 1) for the correction of myopic astigmatism with spherical equivalent ranging from -3.0D to less than or equal to -15.0D (in the spectacle plane) with cylinder (spectacle plane) of 1.0D to 4.0D; 2) for the reduction of myopic astigmatism with spherical equivalent ranging from greater than -15.0D to -20.0D (in the spectacle plane) with cylinder (spectacle plane) 1.0D to 4.0D; 3. with an anterior chamber depth (ACD) of 3.00 mm or greater, when measured from the corneal endothelium to the anterior surface of the crystalline lens and a stable refractive history (within 0.5D for both spherical equivalent and cylinder for 1 year prior to implantation); and4) The Visian TICL is intended for placement in the posterior chamber (ciliary sulcus) of the phakic eye."}

{"project":"PMA_age_indications","denotations":[{"id":"T7","span":{"begin":107,"end":109},"obj":"age_start"},{"id":"T1","span":{"begin":107,"end":118},"obj":"age_range"},{"id":"T6","span":{"begin":110,"end":112},"obj":"age_end"},{"id":"T8","span":{"begin":113,"end":118},"obj":"age_end_unit"}],"text":"Approval for the Visian Toric ICL (Implantable Collamer Lens). The device is indicated for use in patients 21-45 years of age: 1) for the correction of myopic astigmatism with spherical equivalent ranging from -3.0D to less than or equal to -15.0D (in the spectacle plane) with cylinder (spectacle plane) of 1.0D to 4.0D; 2) for the reduction of myopic astigmatism with spherical equivalent ranging from greater than -15.0D to -20.0D (in the spectacle plane) with cylinder (spectacle plane) 1.0D to 4.0D; 3. with an anterior chamber depth (ACD) of 3.00 mm or greater, when measured from the corneal endothelium to the anterior surface of the crystalline lens and a stable refractive history (within 0.5D for both spherical equivalent and cylinder for 1 year prior to implantation); and4) The Visian TICL is intended for placement in the posterior chamber (ciliary sulcus) of the phakic eye."}

{"project":"updated_tagging_age_PMA_annotations","denotations":[{"id":"T1","span":{"begin":107,"end":118},"obj":"age_range"},{"id":"T6","span":{"begin":110,"end":112},"obj":"age_end"},{"id":"T7","span":{"begin":107,"end":109},"obj":"age_start"},{"id":"T8","span":{"begin":113,"end":118},"obj":"age_end_unit"}],"text":"Approval for the Visian Toric ICL (Implantable Collamer Lens). The device is indicated for use in patients 21-45 years of age: 1) for the correction of myopic astigmatism with spherical equivalent ranging from -3.0D to less than or equal to -15.0D (in the spectacle plane) with cylinder (spectacle plane) of 1.0D to 4.0D; 2) for the reduction of myopic astigmatism with spherical equivalent ranging from greater than -15.0D to -20.0D (in the spectacle plane) with cylinder (spectacle plane) 1.0D to 4.0D; 3. with an anterior chamber depth (ACD) of 3.00 mm or greater, when measured from the corneal endothelium to the anterior surface of the crystalline lens and a stable refractive history (within 0.5D for both spherical equivalent and cylinder for 1 year prior to implantation); and4) The Visian TICL is intended for placement in the posterior chamber (ciliary sulcus) of the phakic eye."}