DevicePMAs@therightstef:P190016_S000 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":22,"end":28},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25700"},{"id":"T3","span":{"begin":36,"end":42},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C62103"},{"id":"T4","span":{"begin":67,"end":78},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C70905"},{"id":"T5","span":{"begin":83,"end":89},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C45518"},{"id":"T6","span":{"begin":92,"end":109},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C122608"},{"id":"T7","span":{"begin":105,"end":109},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C41277"},{"id":"T8","span":{"begin":125,"end":129},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C41277"},{"id":"T9","span":{"begin":130,"end":138},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C61560"},{"id":"T10","span":{"begin":139,"end":145},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25700"},{"id":"T11","span":{"begin":149,"end":158},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C14154"},{"id":"T12","span":{"begin":189,"end":194},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C17600"},{"id":"T13","span":{"begin":217,"end":224},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25639"},{"id":"T14","span":{"begin":254,"end":260},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25700"},{"id":"T15","span":{"begin":282,"end":299},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C122608"},{"id":"T16","span":{"begin":295,"end":299},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C41277"},{"id":"T17","span":{"begin":306,"end":311},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C67263"},{"id":"T18","span":{"begin":360,"end":366},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25700"},{"id":"T19","span":{"begin":382,"end":393},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C61517"},{"id":"T20","span":{"begin":406,"end":411},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C67263"},{"id":"T21","span":{"begin":477,"end":488},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C61517"},{"id":"T22","span":{"begin":501,"end":506},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C67263"},{"id":"T23","span":{"begin":582,"end":591},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C61367"},{"id":"T24","span":{"begin":595,"end":600},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C67263"},{"id":"T25","span":{"begin":619,"end":636},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C12502"},{"id":"T26","span":{"begin":628,"end":636},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C12749"},{"id":"T27","span":{"begin":684,"end":690},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25700"},{"id":"T28","span":{"begin":694,"end":703},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C14154"},{"id":"T29","span":{"begin":734,"end":739},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C17600"},{"id":"T30","span":{"begin":760,"end":777},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C122608"},{"id":"T31","span":{"begin":773,"end":777},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C41277"},{"id":"T32","span":{"begin":778,"end":787},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C126366"},{"id":"T33","span":{"begin":803,"end":807},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C41277"},{"id":"T34","span":{"begin":808,"end":816},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C61560"},{"id":"T35","span":{"begin":863,"end":874},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C61517"},{"id":"T36","span":{"begin":887,"end":892},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C67263"},{"id":"T37","span":{"begin":968,"end":977},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C61367"},{"id":"T38","span":{"begin":981,"end":986},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C67263"},{"id":"T39","span":{"begin":1005,"end":1022},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C12502"},{"id":"T40","span":{"begin":1014,"end":1022},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C12749"},{"id":"T41","span":{"begin":1070,"end":1076},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25700"},{"id":"T42","span":{"begin":1080,"end":1089},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C14154"},{"id":"T43","span":{"begin":1120,"end":1125},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C17600"},{"id":"T44","span":{"begin":1146,"end":1163},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C122608"},{"id":"T45","span":{"begin":1159,"end":1163},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C41277"},{"id":"T46","span":{"begin":1164,"end":1173},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C126366"},{"id":"T47","span":{"begin":1189,"end":1193},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C41277"},{"id":"T48","span":{"begin":1194,"end":1202},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C61560"},{"id":"T49","span":{"begin":1203,"end":1209},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25700"}],"text":"Approval for the Tula System. This device is intended to create a myringotomy and insert a tympanostomy tube using the Tula Tube Delivery System in pediatric (aged 6 months and older) and adult patients indicated to receive tympanostomy tubes. The Tula System is used to deliver a tympanostomy tube under local anesthesia induced using the Tula Iontophoresis System and TYMBION, a combination of an amide local anesthetic and an alpha- and beta-adrenergic agonist. TYMBION, a combination of an amide local anesthetic and an alpha- and beta-adrenergic agonist, is indicated for the induction of local anesthesia of the tympanic membrane via iontophoresis using the Tula Iontophoresis System in pediatric (aged 6 months and older) and adult patients undergoing tympanostomy tube placement using the Tula Tube Delivery SystemDrug Indications and Usage: TYMBION, a combination of an amide local anesthetic and an alpha- and beta-adrenergic agonist, is indicated for the induction of local anesthesia of the tympanic membrane via iontophoresis using the Tula Iontophoresis System in pediatric (aged 6 months and older) and adult patients undergoing tympanostomy tube placement using the Tula Tube Delivery System."}

{"project":"consensus_PMA_Age_Indications","denotations":[{"id":"T1","span":{"begin":149,"end":158},"obj":"age_category"},{"id":"T7","span":{"begin":165,"end":183},"obj":"age_range"},{"id":"T11","span":{"begin":165,"end":166},"obj":"age_start"},{"id":"T14","span":{"begin":167,"end":173},"obj":"age_start_unit"},{"id":"T17","span":{"begin":178,"end":183},"obj":"age_end"},{"id":"T2","span":{"begin":189,"end":194},"obj":"age_category"},{"id":"T3","span":{"begin":694,"end":703},"obj":"age_category"},{"id":"T8","span":{"begin":710,"end":728},"obj":"age_range"},{"id":"T10","span":{"begin":710,"end":711},"obj":"age_start"},{"id":"T13","span":{"begin":712,"end":718},"obj":"age_start_unit"},{"id":"T16","span":{"begin":723,"end":728},"obj":"age_end"},{"id":"T4","span":{"begin":734,"end":739},"obj":"age_category"},{"id":"T5","span":{"begin":1080,"end":1089},"obj":"age_category"},{"id":"T9","span":{"begin":1096,"end":1114},"obj":"age_range"},{"id":"T12","span":{"begin":1096,"end":1097},"obj":"age_start"},{"id":"T15","span":{"begin":1098,"end":1104},"obj":"age_start_unit"},{"id":"T18","span":{"begin":1109,"end":1114},"obj":"age_end"},{"id":"T6","span":{"begin":1120,"end":1125},"obj":"age_category"}],"text":"Approval for the Tula System. This device is intended to create a myringotomy and insert a tympanostomy tube using the Tula Tube Delivery System in pediatric (aged 6 months and older) and adult patients indicated to receive tympanostomy tubes. The Tula System is used to deliver a tympanostomy tube under local anesthesia induced using the Tula Iontophoresis System and TYMBION, a combination of an amide local anesthetic and an alpha- and beta-adrenergic agonist. TYMBION, a combination of an amide local anesthetic and an alpha- and beta-adrenergic agonist, is indicated for the induction of local anesthesia of the tympanic membrane via iontophoresis using the Tula Iontophoresis System in pediatric (aged 6 months and older) and adult patients undergoing tympanostomy tube placement using the Tula Tube Delivery SystemDrug Indications and Usage: TYMBION, a combination of an amide local anesthetic and an alpha- and beta-adrenergic agonist, is indicated for the induction of local anesthesia of the tympanic membrane via iontophoresis using the Tula Iontophoresis System in pediatric (aged 6 months and older) and adult patients undergoing tympanostomy tube placement using the Tula Tube Delivery System."}

{"project":"age_PMA_annotations","denotations":[{"id":"T1","span":{"begin":165,"end":166},"obj":"population"},{"id":"T2","span":{"begin":1096,"end":1097},"obj":"population"},{"id":"T3","span":{"begin":710,"end":711},"obj":"population"}],"text":"Approval for the Tula System. This device is intended to create a myringotomy and insert a tympanostomy tube using the Tula Tube Delivery System in pediatric (aged 6 months and older) and adult patients indicated to receive tympanostomy tubes. The Tula System is used to deliver a tympanostomy tube under local anesthesia induced using the Tula Iontophoresis System and TYMBION, a combination of an amide local anesthetic and an alpha- and beta-adrenergic agonist. TYMBION, a combination of an amide local anesthetic and an alpha- and beta-adrenergic agonist, is indicated for the induction of local anesthesia of the tympanic membrane via iontophoresis using the Tula Iontophoresis System in pediatric (aged 6 months and older) and adult patients undergoing tympanostomy tube placement using the Tula Tube Delivery SystemDrug Indications and Usage: TYMBION, a combination of an amide local anesthetic and an alpha- and beta-adrenergic agonist, is indicated for the induction of local anesthesia of the tympanic membrane via iontophoresis using the Tula Iontophoresis System in pediatric (aged 6 months and older) and adult patients undergoing tympanostomy tube placement using the Tula Tube Delivery System."}

{"project":"PMA_age_indications","denotations":[{"id":"T1","span":{"begin":149,"end":158},"obj":"age_category"},{"id":"T11","span":{"begin":165,"end":166},"obj":"age_start"},{"id":"T7","span":{"begin":165,"end":183},"obj":"age_range"},{"id":"T14","span":{"begin":167,"end":173},"obj":"age_start_unit"},{"id":"T17","span":{"begin":178,"end":183},"obj":"age_end"},{"id":"T2","span":{"begin":189,"end":194},"obj":"age_category"},{"id":"T3","span":{"begin":694,"end":703},"obj":"age_category"},{"id":"T10","span":{"begin":710,"end":711},"obj":"age_start"},{"id":"T8","span":{"begin":710,"end":728},"obj":"age_range"},{"id":"T13","span":{"begin":712,"end":718},"obj":"age_start_unit"},{"id":"T16","span":{"begin":723,"end":728},"obj":"age_end"},{"id":"T4","span":{"begin":734,"end":739},"obj":"age_category"},{"id":"T5","span":{"begin":1080,"end":1089},"obj":"age_category"},{"id":"T12","span":{"begin":1096,"end":1097},"obj":"age_start"},{"id":"T9","span":{"begin":1096,"end":1114},"obj":"age_range"},{"id":"T15","span":{"begin":1098,"end":1104},"obj":"age_start_unit"},{"id":"T18","span":{"begin":1109,"end":1114},"obj":"age_end"},{"id":"T6","span":{"begin":1120,"end":1125},"obj":"age_category"}],"text":"Approval for the Tula System. This device is intended to create a myringotomy and insert a tympanostomy tube using the Tula Tube Delivery System in pediatric (aged 6 months and older) and adult patients indicated to receive tympanostomy tubes. The Tula System is used to deliver a tympanostomy tube under local anesthesia induced using the Tula Iontophoresis System and TYMBION, a combination of an amide local anesthetic and an alpha- and beta-adrenergic agonist. TYMBION, a combination of an amide local anesthetic and an alpha- and beta-adrenergic agonist, is indicated for the induction of local anesthesia of the tympanic membrane via iontophoresis using the Tula Iontophoresis System in pediatric (aged 6 months and older) and adult patients undergoing tympanostomy tube placement using the Tula Tube Delivery SystemDrug Indications and Usage: TYMBION, a combination of an amide local anesthetic and an alpha- and beta-adrenergic agonist, is indicated for the induction of local anesthesia of the tympanic membrane via iontophoresis using the Tula Iontophoresis System in pediatric (aged 6 months and older) and adult patients undergoing tympanostomy tube placement using the Tula Tube Delivery System."}

{"project":"Age_blah","denotations":[{"id":"T1","span":{"begin":149,"end":158},"obj":"age_category"},{"id":"T10","span":{"begin":734,"end":739},"obj":"age_category"},{"id":"T11","span":{"begin":189,"end":194},"obj":"age_category"},{"id":"T3","span":{"begin":694,"end":703},"obj":"age_category"},{"id":"T7","span":{"begin":1080,"end":1089},"obj":"age_category"},{"id":"T9","span":{"begin":1120,"end":1125},"obj":"age_category"},{"id":"T12","span":{"begin":165,"end":166},"obj":"age_start"},{"id":"T13","span":{"begin":167,"end":173},"obj":"age_start_unit"},{"id":"T14","span":{"begin":178,"end":183},"obj":"age_end"},{"id":"T15","span":{"begin":710,"end":711},"obj":"age_start"},{"id":"T16","span":{"begin":712,"end":718},"obj":"age_start_unit"},{"id":"T17","span":{"begin":723,"end":728},"obj":"age_end"},{"id":"T18","span":{"begin":1096,"end":1097},"obj":"age_start"},{"id":"T19","span":{"begin":1098,"end":1104},"obj":"age_start_unit"},{"id":"T20","span":{"begin":1109,"end":1114},"obj":"age_end"},{"id":"T21","span":{"begin":165,"end":183},"obj":"age_range"},{"id":"T22","span":{"begin":710,"end":728},"obj":"age_range"},{"id":"T23","span":{"begin":1096,"end":1114},"obj":"age_range"}],"text":"Approval for the Tula System. This device is intended to create a myringotomy and insert a tympanostomy tube using the Tula Tube Delivery System in pediatric (aged 6 months and older) and adult patients indicated to receive tympanostomy tubes. The Tula System is used to deliver a tympanostomy tube under local anesthesia induced using the Tula Iontophoresis System and TYMBION, a combination of an amide local anesthetic and an alpha- and beta-adrenergic agonist. TYMBION, a combination of an amide local anesthetic and an alpha- and beta-adrenergic agonist, is indicated for the induction of local anesthesia of the tympanic membrane via iontophoresis using the Tula Iontophoresis System in pediatric (aged 6 months and older) and adult patients undergoing tympanostomy tube placement using the Tula Tube Delivery SystemDrug Indications and Usage: TYMBION, a combination of an amide local anesthetic and an alpha- and beta-adrenergic agonist, is indicated for the induction of local anesthesia of the tympanic membrane via iontophoresis using the Tula Iontophoresis System in pediatric (aged 6 months and older) and adult patients undergoing tympanostomy tube placement using the Tula Tube Delivery System."}

{"project":"Age_blah","denotations":[{"id":"T1","span":{"begin":149,"end":158},"obj":"age_category"},{"id":"T10","span":{"begin":734,"end":739},"obj":"age_category"},{"id":"T11","span":{"begin":189,"end":194},"obj":"age_category"},{"id":"T3","span":{"begin":694,"end":703},"obj":"age_category"},{"id":"T7","span":{"begin":1080,"end":1089},"obj":"age_category"},{"id":"T9","span":{"begin":1120,"end":1125},"obj":"age_category"},{"id":"T12","span":{"begin":165,"end":166},"obj":"age_start"},{"id":"T13","span":{"begin":167,"end":173},"obj":"age_start_unit"},{"id":"T14","span":{"begin":178,"end":183},"obj":"age_end"},{"id":"T15","span":{"begin":710,"end":711},"obj":"age_start"},{"id":"T16","span":{"begin":712,"end":718},"obj":"age_start_unit"},{"id":"T17","span":{"begin":723,"end":728},"obj":"age_end"},{"id":"T18","span":{"begin":1096,"end":1097},"obj":"age_start"},{"id":"T19","span":{"begin":1098,"end":1104},"obj":"age_start_unit"},{"id":"T20","span":{"begin":1109,"end":1114},"obj":"age_end"},{"id":"T21","span":{"begin":165,"end":183},"obj":"age_range"},{"id":"T22","span":{"begin":710,"end":728},"obj":"age_range"},{"id":"T23","span":{"begin":1096,"end":1114},"obj":"age_range"}],"text":"Approval for the Tula System. This device is intended to create a myringotomy and insert a tympanostomy tube using the Tula Tube Delivery System in pediatric (aged 6 months and older) and adult patients indicated to receive tympanostomy tubes. The Tula System is used to deliver a tympanostomy tube under local anesthesia induced using the Tula Iontophoresis System and TYMBION, a combination of an amide local anesthetic and an alpha- and beta-adrenergic agonist. TYMBION, a combination of an amide local anesthetic and an alpha- and beta-adrenergic agonist, is indicated for the induction of local anesthesia of the tympanic membrane via iontophoresis using the Tula Iontophoresis System in pediatric (aged 6 months and older) and adult patients undergoing tympanostomy tube placement using the Tula Tube Delivery SystemDrug Indications and Usage: TYMBION, a combination of an amide local anesthetic and an alpha- and beta-adrenergic agonist, is indicated for the induction of local anesthesia of the tympanic membrane via iontophoresis using the Tula Iontophoresis System in pediatric (aged 6 months and older) and adult patients undergoing tympanostomy tube placement using the Tula Tube Delivery System."}

{"project":"updated_tagging_age_PMA_annotations","denotations":[{"id":"T1","span":{"begin":149,"end":158},"obj":"age_category"},{"id":"T2","span":{"begin":189,"end":194},"obj":"age_category"},{"id":"T3","span":{"begin":694,"end":703},"obj":"age_category"},{"id":"T4","span":{"begin":734,"end":739},"obj":"age_category"},{"id":"T5","span":{"begin":1080,"end":1089},"obj":"age_category"},{"id":"T6","span":{"begin":1120,"end":1125},"obj":"age_category"},{"id":"T7","span":{"begin":165,"end":183},"obj":"age_range"},{"id":"T8","span":{"begin":710,"end":728},"obj":"age_range"},{"id":"T9","span":{"begin":1096,"end":1114},"obj":"age_range"},{"id":"T10","span":{"begin":710,"end":711},"obj":"age_start"},{"id":"T11","span":{"begin":165,"end":166},"obj":"age_start"},{"id":"T12","span":{"begin":1096,"end":1097},"obj":"age_start"},{"id":"T13","span":{"begin":712,"end":718},"obj":"age_start_unit"},{"id":"T14","span":{"begin":167,"end":173},"obj":"age_start_unit"},{"id":"T15","span":{"begin":1098,"end":1104},"obj":"age_start_unit"},{"id":"T16","span":{"begin":723,"end":728},"obj":"age_end"},{"id":"T17","span":{"begin":178,"end":183},"obj":"age_end"},{"id":"T18","span":{"begin":1109,"end":1114},"obj":"age_end"}],"text":"Approval for the Tula System. This device is intended to create a myringotomy and insert a tympanostomy tube using the Tula Tube Delivery System in pediatric (aged 6 months and older) and adult patients indicated to receive tympanostomy tubes. The Tula System is used to deliver a tympanostomy tube under local anesthesia induced using the Tula Iontophoresis System and TYMBION, a combination of an amide local anesthetic and an alpha- and beta-adrenergic agonist. TYMBION, a combination of an amide local anesthetic and an alpha- and beta-adrenergic agonist, is indicated for the induction of local anesthesia of the tympanic membrane via iontophoresis using the Tula Iontophoresis System in pediatric (aged 6 months and older) and adult patients undergoing tympanostomy tube placement using the Tula Tube Delivery SystemDrug Indications and Usage: TYMBION, a combination of an amide local anesthetic and an alpha- and beta-adrenergic agonist, is indicated for the induction of local anesthesia of the tympanic membrane via iontophoresis using the Tula Iontophoresis System in pediatric (aged 6 months and older) and adult patients undergoing tympanostomy tube placement using the Tula Tube Delivery System."}