DevicePMAs@therightstef:P980023_S016 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":105,"end":109},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C42614"},{"id":"T3","span":{"begin":142,"end":145},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25340"},{"id":"T4","span":{"begin":149,"end":160},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C79874"},{"id":"T5","span":{"begin":195,"end":199},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25474"},{"id":"T6","span":{"begin":231,"end":234},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25340"},{"id":"T7","span":{"begin":243,"end":247},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25552"},{"id":"T8","span":{"begin":248,"end":254},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25700"},{"id":"T9","span":{"begin":290,"end":293},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25340"},{"id":"T10","span":{"begin":308,"end":311},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C106184"}],"text":"Approval for changes in component dimensions. The device, as modified, will be marketed under the trade name kentrox sl and is indicated for use in conjunction with a biotronik icd. Currently, data is not available regarding the use of this lead system with icds of other manufacturers. Use of other icds may adversely affect sensing and/or therapy delivery."}