DevicePMAs@therightstef:P950037_S048 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":16,"end":26},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25406"},{"id":"T3","span":{"begin":33,"end":37},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C42614"},{"id":"T4","span":{"begin":71,"end":75},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25552"},{"id":"T5","span":{"begin":80,"end":84},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C70592"},{"id":"T6","span":{"begin":88,"end":93},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C45367"},{"id":"T7","span":{"begin":206,"end":210},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C42614"},{"id":"T8","span":{"begin":224,"end":231},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C43386"},{"id":"T9","span":{"begin":236,"end":248},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C123937"},{"id":"T10","span":{"begin":274,"end":278},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25552"},{"id":"T11","span":{"begin":296,"end":305},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C160628"},{"id":"T12","span":{"begin":339,"end":344},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25228"},{"id":"T13","span":{"begin":339,"end":351},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C12868"},{"id":"T14","span":{"begin":355,"end":360},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25228"},{"id":"T15","span":{"begin":355,"end":370},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C12870"},{"id":"T16","span":{"begin":374,"end":385},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C79874"},{"id":"T17","span":{"begin":403,"end":408},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25749"}],"text":"Approval for an additional trade name for the market approved setrox s lead, as well as minor changes to the accessories, packaging, and labeling. The device, as modified, will be marketed under the trade name dextrus, and labeled for distribution by guidant. The dextrus lead is indicated for permanent pacing and sensing in either the right atrium or right ventricle in conjunction with implantable pulse generators with is-1 headers."}