DevicePMAs@therightstef:P150029_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":36,"end":42},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C62103"},{"id":"T3","span":{"begin":113,"end":119},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C28220"},{"id":"T4","span":{"begin":166,"end":172},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25198"},{"id":"T5","span":{"begin":186,"end":193},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C2831"},{"id":"T6","span":{"begin":242,"end":253},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C48191"},{"id":"T7","span":{"begin":294,"end":299},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C12434"},{"id":"T8","span":{"begin":294,"end":307},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C94312"},{"id":"T9","span":{"begin":300,"end":307},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C2831"},{"id":"T10","span":{"begin":308,"end":319},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C48191"},{"id":"T11","span":{"begin":337,"end":345},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C44275"},{"id":"T12","span":{"begin":346,"end":350},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C18002"},{"id":"T13","span":{"begin":370,"end":376},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C62103"},{"id":"T14","span":{"begin":383,"end":394},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C48191"},{"id":"T15","span":{"begin":395,"end":404},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25452"},{"id":"T16","span":{"begin":427,"end":430},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C106184"},{"id":"T17","span":{"begin":448,"end":456},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C16464"},{"id":"T18","span":{"begin":463,"end":471},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C20342"},{"id":"T19","span":{"begin":472,"end":478},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25396"},{"id":"T20","span":{"begin":484,"end":492},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C45314"},{"id":"T21","span":{"begin":496,"end":506},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C15363"},{"id":"T22","span":{"begin":528,"end":539},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C48191"},{"id":"T23","span":{"begin":540,"end":543},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C106184"},{"id":"T24","span":{"begin":550,"end":564},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25737"},{"id":"T25","span":{"begin":580,"end":587},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C2831"},{"id":"T26","span":{"begin":588,"end":593},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25554"},{"id":"T27","span":{"begin":678,"end":681},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C106184"},{"id":"T28","span":{"begin":746,"end":758},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C28180"},{"id":"T29","span":{"begin":759,"end":762},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25340"},{"id":"T30","span":{"begin":787,"end":791},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25474"},{"id":"T31","span":{"begin":860,"end":864},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25474"},{"id":"T32","span":{"begin":892,"end":898},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C42729"},{"id":"T33","span":{"begin":933,"end":941},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25543"},{"id":"T34","span":{"begin":1011,"end":1014},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25340"},{"id":"T35","span":{"begin":1068,"end":1079},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C53610"},{"id":"T36","span":{"begin":1085,"end":1093},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C44275"},{"id":"T37","span":{"begin":1094,"end":1102},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C14159"}],"text":"Approval for the iPro2 System. This device is indicated for: The iPro2 Recorder is to be used with either Enlite sensor or Sof-Sensor and is intended to continuously record interstitial glucose levels in persons with diabetes mellitus. This information is intended to supplement, not replace, blood glucose information obtained using a standard home glucose-monitoring device. The information collected by the iPro2 Recorder may be uploaded to a computer (with Internet access) and reviewed by healthcare professionals. This information may allow identification of patterns of glucose level excursions above or below the desired range, facilitating therapy adjustments which may minimize these excursions. The iPro2 system: 1)\tIs intended for prescription use only; 2)\tDoes not allow data to be made available directly to patients in real time; 3)\tProvides data that will be available for review by physicians after the recording interval (up to 144 hours);4)\tIs intended for occasional rather than everyday use; and5)\tIs to be used only as a supplement, and not a replacement for, standard invasive measurement."}