DevicePMAs@therightstef:P860003_S031 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":13,"end":24},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C16548"},{"id":"T3","span":{"begin":62,"end":68},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25700"},{"id":"T4","span":{"begin":112,"end":120},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C63553"},{"id":"T5","span":{"begin":134,"end":144},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C153402"},{"id":"T6","span":{"begin":145,"end":153},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C52474"},{"id":"T7","span":{"begin":163,"end":170},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25471"},{"id":"T8","span":{"begin":171,"end":181},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C48151"},{"id":"T9","span":{"begin":195,"end":205},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C153402"},{"id":"T10","span":{"begin":206,"end":214},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C52474"},{"id":"T11","span":{"begin":341,"end":346},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25278"},{"id":"T12","span":{"begin":347,"end":357},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C61372"},{"id":"T13","span":{"begin":358,"end":364},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25700"},{"id":"T14","span":{"begin":390,"end":395},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25278"},{"id":"T15","span":{"begin":402,"end":408},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C42721"},{"id":"T16","span":{"begin":413,"end":418},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25278"},{"id":"T17","span":{"begin":513,"end":522},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C15368"},{"id":"T18","span":{"begin":551,"end":555},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C164662"},{"id":"T19","span":{"begin":570,"end":576},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25700"},{"id":"T20","span":{"begin":592,"end":598},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C62103"},{"id":"T21","span":{"begin":616,"end":619},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25340"},{"id":"T22","span":{"begin":700,"end":711},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C643"},{"id":"T23","span":{"begin":807,"end":817},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C101516"},{"id":"T24","span":{"begin":818,"end":827},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C15368"},{"id":"T25","span":{"begin":835,"end":839},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C12470"},{"id":"T26","span":{"begin":858,"end":867},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C13316"},{"id":"T27","span":{"begin":875,"end":883},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C3208"}],"text":"Approval for engineering changes to the UVAR(R) Photopheresis System including the following: 1) Replacing the obsolete Haemotronics centrifuge assembly with the current generation Haemotronics centrifuge assembly that includes an optical detector; 2) Replacing the electronic roller pumps and mechanical clamps with a pneumatically-driven fluid management system, including the cassette, fluid logic module and fluid logic controller; 3) Modifying the Photoceptor(R) photoactivation chamber; 4) Redesigning the treatment kit; and 5) Redesigning the user interface and system software. The device is indicated for use in the ultraviolet-A (UVA) irradiation, in the presence of the photoactive drug methoxsalen (8-methoxypsoralen or 8-MOP), of extracorporeally circulating leukocyte-enriched blood, in the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL), in persons who have not been responsive to other therapy."}