[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-SDZ":3},{"classification":4,"mappedDevices":33,"similarCandidates":34,"relatedClassifications":117,"syncDates":118,"translation":125,"marketSummary":132,"recalls":147,"k510s":149,"pmas":151},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":9,"medical_specialty_description":10,"review_panel":11,"submission_type_id":12,"definition":13,"implant_flag":14,"life_sustain_support_flag":15,"gmp_exempt_flag":15,"raw":16,"created_at":28,"updated_at":29,"recall_count":30,"latest_recall_date":31,"k510_count":30,"pma_count":32,"event_count":30},5422,"SDZ","Endovascular System For Treatment Of Ascending Aorta And Aortic Arch Lesions","3","","Unknown","CV","2","Endovascular Repair of Ascending Aorta and Aortic Arch Lesions",true,false,{"openfda":17,"definition":13,"device_name":7,"review_code":9,"device_class":8,"implant_flag":25,"product_code":6,"review_panel":11,"gmp_exempt_flag":26,"third_party_flag":26,"medical_specialty":9,"regulation_number":9,"submission_type_id":12,"unclassified_reason":9,"life_sustain_support_flag":26,"medical_specialty_description":10,"summary_malfunction_reporting":27},{"fei_number":18,"pma_number":21,"registration_number":24},[19,20],"3009304068","2017233",[22,23],"P250033","P210032",[19,20],"Y","N","Ineligible","2026-08-18T05:52:52.566809+00:00","2026-08-24T02:00:47.318533+00:00",0,null,4,[],[35,44,53,61,69,76,84,93,100,108],{"medical_device_id":36,"generic_name":37,"class_classification":38,"jmdn_code":39,"name_similarity":40,"definition_similarity":41,"vector_similarity":42,"score":43},1300,"循環器用超音波画像診断装置","Ⅱ","40763000",0.241758,0.0596206,0.639482,0.031754,{"medical_device_id":45,"generic_name":46,"class_classification":47,"jmdn_code":48,"name_similarity":49,"definition_similarity":50,"vector_similarity":51,"score":52},1171,"中心循環系ステントグラフト","Ⅳ","47932114",0.175824,0.0660661,0.637262,0.0270125,{"medical_device_id":54,"generic_name":55,"class_classification":38,"jmdn_code":56,"name_similarity":57,"definition_similarity":58,"vector_similarity":59,"score":60},1257,"X線CT組合せ型循環器X線診断装置","70003000",0.17,0.140496,0.605618,0.0240964,{"medical_device_id":62,"generic_name":63,"class_classification":47,"jmdn_code":64,"name_similarity":65,"definition_similarity":66,"vector_similarity":67,"score":68},106,"中心循環系閉塞術用血管内カテーテル","32584004",0.242105,0.08,0.589733,0.0163934,{"medical_device_id":70,"generic_name":71,"class_classification":47,"jmdn_code":72,"name_similarity":73,"definition_similarity":74,"vector_similarity":75,"score":68},220,"大動脈用ステントグラフト","70488000",0.144737,0.074184,0.681816,{"medical_device_id":77,"generic_name":78,"class_classification":38,"jmdn_code":79,"name_similarity":80,"definition_similarity":81,"vector_similarity":82,"score":83},2229,"外科手術用大動脈クランプ","34947000",0.0882353,0.0995025,0.660234,0.016129,{"medical_device_id":85,"generic_name":86,"class_classification":87,"jmdn_code":88,"name_similarity":89,"definition_similarity":90,"vector_similarity":91,"score":92},559,"血管用ステント","Ⅲ","36035003",0.152778,0.0797342,0.644298,0.015873,{"medical_device_id":94,"generic_name":95,"class_classification":38,"jmdn_code":96,"name_similarity":97,"definition_similarity":98,"vector_similarity":99,"score":92},3198,"禁煙治療補助システム","71087002",0.238636,0.0531915,0.53783,{"medical_device_id":101,"generic_name":102,"class_classification":47,"jmdn_code":103,"name_similarity":104,"definition_similarity":105,"vector_similarity":106,"score":107},66,"中心循環系ガイディング用血管内カテーテル","17846104",0.227723,0.1,0.593532,0.015625,{"medical_device_id":109,"generic_name":110,"class_classification":111,"jmdn_code":112,"name_similarity":113,"definition_similarity":114,"vector_similarity":115,"score":116},3255,"循環器X線診断装置用電動式患者台","Ⅰ","40660000",0.222222,0.0490798,0.582193,0.0153846,[],{"510k":119,"classification":120,"enforcement":121,"event":122,"pma":123,"warning_letter":124},"2026-08-24T02:00:50.297+00:00","2026-08-24T02:00:49.319+00:00","2026-08-24T02:00:50.059+00:00","2026-08-24T04:00:49.186+00:00","2026-08-24T02:00:50.609+00:00","2026-08-20T03:28:02.95+00:00",{"product_code":6,"device_name_ja":126,"definition_ja":127,"commentary_ja":128,"model_name":129,"source_hash":130,"reviewed_by":31,"reviewed_at":31,"created_at":131,"updated_at":131},"上行大動脈・大動脈弓病変治療用血管内システム","上行大動脈及び大動脈弓病変の血管内修復である。","本機器は米国においてクラスIIIに分類されており、市販前承認（PMA）による審査の対象となっています。クラスIIIは人の生命維持や健康に及ぼすリスクが最も高い機器区分であり、有効性及び安全性に関する十分な科学的根拠を示す臨床データの提出が求められる、最も厳格な審査プロセスが適用されます。","claude-sonnet-5","3af8869da014bb6dc47efbefe812dbd9155019abffeeac3ddeb83828cfc6539e","2026-08-24T03:40:21.731962+00:00",{"product_code":6,"summary_ja":133,"stats":134,"stats_hash":145,"model_name":129,"created_at":146,"updated_at":146},"本製品はクラス III の医療機器であり、PMA（市販前承認）区分において本承認が1件、一部変更承認が3件確認されており、最新の判定は2026年7月となっています。510(k)による届出実績は確認されていません。不具合報告（MDR）および回収については、いずれも累計件数0件であり、報告は確認されていません。",{"pma":135,"k510":139,"as_of":140,"events":141,"recalls":142,"top_problems":144},{"latest":136,"originals":137,"supplements":138},"2026-07-24",1,3,{"total":30,"last5y":30,"latest":31,"applicants":30},"2026-08",{"death":30,"other":30,"total":30,"injury":30,"last5y":30,"malfunction":30,"latest_month":31},{"total":30,"last5y":30,"latest":31,"class_i":30,"class_ii":30,"class_iii":30,"top_root_causes":143},[],[],"4a07a98698cd96de0a4fc48985545bc4dd4e17ca4650af5f637fd85d056ba161","2026-08-24T05:23:16.025025+00:00",{"items":148,"total":30},[],{"items":150,"total":30},[],{"items":152,"total":32},[153,157,161,163],{"pma_number":22,"supplement_number":154,"trade_name":155,"applicant":156,"decision_date":136},"S002","NEXUS Aortic Arch Stent Graft System","Endospan , Ltd.",{"pma_number":22,"supplement_number":158,"trade_name":159,"applicant":156,"decision_date":160},"S001","NEXUS® Aortic Arch Stent Graft System","2026-05-20",{"pma_number":22,"supplement_number":9,"trade_name":155,"applicant":156,"decision_date":162},"2026-04-02",{"pma_number":23,"supplement_number":164,"trade_name":165,"applicant":166,"decision_date":167},"S015","GORE TAG Thoracic Branch Endoprosthesis (TBE Device)","W. L. Gore & Associates, Inc.","2025-04-11"]