DevicePMAs@therightstef:P950020_S072 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":59,"end":67},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C17446"},{"id":"T3","span":{"begin":78,"end":84},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C62103"},{"id":"T4","span":{"begin":103,"end":116},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C84382"},{"id":"T5","span":{"begin":131,"end":137},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C62103"},{"id":"T6","span":{"begin":185,"end":189},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C42614"},{"id":"T7","span":{"begin":200,"end":208},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C41072"},{"id":"T8","span":{"begin":299,"end":307},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C41072"},{"id":"T9","span":{"begin":325,"end":332},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25634"},{"id":"T10","span":{"begin":346,"end":356},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25578"},{"id":"T11","span":{"begin":357,"end":366},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C150246"},{"id":"T12","span":{"begin":398,"end":402},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25227"},{"id":"T13","span":{"begin":403,"end":411},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25195"},{"id":"T14","span":{"begin":430,"end":436},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C3824"},{"id":"T15","span":{"begin":470,"end":476},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25702"},{"id":"T16","span":{"begin":477,"end":483},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C3824"},{"id":"T17","span":{"begin":491,"end":498},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C89277"},{"id":"T18","span":{"begin":530,"end":538},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C75300"},{"id":"T19","span":{"begin":550,"end":556},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25334"},{"id":"T20","span":{"begin":562,"end":569},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C14169"},{"id":"T21","span":{"begin":589,"end":595},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25334"},{"id":"T22","span":{"begin":598,"end":607},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25641"},{"id":"T23","span":{"begin":615,"end":623},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25285"},{"id":"T24","span":{"begin":679,"end":685},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C62103"},{"id":"T25","span":{"begin":687,"end":692},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C64650"},{"id":"T26","span":{"begin":696,"end":704},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C61376"},{"id":"T27","span":{"begin":719,"end":727},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25236"},{"id":"T28","span":{"begin":735,"end":742},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C45312"},{"id":"T29","span":{"begin":758,"end":764},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C3824"},{"id":"T30","span":{"begin":765,"end":772},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C45312"},{"id":"T31","span":{"begin":788,"end":794},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C82334"},{"id":"T32","span":{"begin":845,"end":852},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C48173"}],"text":"Approval for updates to the atherotomes, adhesive, balloon catheter platform, device packaging and the sterilization process. The device, as modified, will be marketed under the trade name WOLVERINE Coronary Cutting Balloon (Monorail \u0026 Over-The-Wire) and is indicated for dilatation of stenoses in coronary arteries for the purpose of improving myocardial perfusion in those circumstances where a high pressure balloon resistant lesion is encountered. In addition, the target lesion should possess the following characteristics: Discrete (\u003c15 mm in length), or tubular (10 mm to 20 mm in length); Reference Vessel Diameter (RVD) of 2.00 mm to 4.00 mm; Readily accessible to the device; Light to moderate tortuosity of proximal vessel segment; Non-angulated lesion segment (\u003c45 Degrees); Smooth angiographic contour; Absence of angiographically visible thrombus and/or calcification."}