[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-SJL":3},{"classification":4,"mappedDevices":21,"similarCandidates":22,"relatedClassifications":125,"syncDates":126,"translation":134,"marketSummary":18,"recalls":141,"k510s":143,"pmas":145},{"id":5,"product_code":6,"device_name":7,"device_class":8,"definition":9,"regulation_number":10,"medical_specialty":10,"medical_specialty_description":11,"review_panel":12,"submission_type_id":13,"implant_flag":14,"life_sustain_support_flag":14,"gmp_exempt_flag":15,"k510_count":16,"pma_count":17,"event_count":16,"recall_count":16,"latest_recall_date":18,"total_record_count":17,"created_at":19,"updated_at":20},77172,"SJL","Heart-Valve, Polymeric","3","This device is a permanent implant intended to replace a heart valve.","","Unknown","CV","2",true,false,0,1,null,"2026-10-19T02:00:40.612407+00:00","2026-10-19T02:02:18.04092+00:00",[],[23,35,52,63,77,87,97,104,111,118],{"score":24,"jmdn_code":25,"generic_name":26,"name_similarity":27,"medical_device_id":28,"vector_similarity":18,"class_classification":29,"definition_similarity":30,"id":28,"category_code":31,"category_name":32,"subcategory_name":33,"data_exist":15,"product_count":34,"company_count":34,"market_size":18,"market_size_unit":18,"growth_ratio":18,"average_price":18,"average_price_unit":18,"domestic_ratio":18},0.0163934,"17581012","人工心肺用安全弁",0.266667,3173,"Ⅱ",0.185714,"器07","内臓機能代用器","血液体外循環機器",2,{"score":36,"jmdn_code":37,"generic_name":38,"name_similarity":39,"medical_device_id":40,"vector_similarity":18,"class_classification":29,"definition_similarity":41,"id":40,"category_code":42,"category_name":43,"subcategory_name":44,"data_exist":14,"product_count":45,"company_count":46,"market_size":47,"market_size_unit":48,"growth_ratio":16,"average_price":49,"average_price_unit":50,"domestic_ratio":51},0.016129,"70279000","止血弁",0.258065,2027,0.146789,"器51","医療用嘴管及び体液誘導管","チューブ及びカテーテル",8,5,1.03,"億円\u002F年",1094,"円\u002F個",100,{"score":53,"jmdn_code":54,"generic_name":55,"name_similarity":56,"medical_device_id":57,"vector_similarity":18,"class_classification":58,"definition_similarity":59,"id":57,"category_code":60,"category_name":61,"subcategory_name":62,"data_exist":15,"product_count":18,"company_count":18,"market_size":18,"market_size_unit":18,"growth_ratio":18,"average_price":18,"average_price_unit":18,"domestic_ratio":18},0.015873,"70467000","電動式ピンチバルブ",0.242424,3868,"Ⅰ",0.150538,"器55","医療用洗浄器","医科用洗浄器",{"score":64,"jmdn_code":65,"generic_name":66,"name_similarity":67,"medical_device_id":68,"vector_similarity":18,"class_classification":69,"definition_similarity":70,"id":68,"category_code":31,"category_name":32,"subcategory_name":71,"data_exist":14,"product_count":72,"company_count":45,"market_size":73,"market_size_unit":48,"growth_ratio":74,"average_price":75,"average_price_unit":76,"domestic_ratio":16},0.015625,"35591100","ウシ心のう膜弁",0.236842,196,"Ⅳ",0.186047,"生体内移植器具",16,89.86,-20.71,79.35,"万円\u002F個",{"score":78,"jmdn_code":79,"generic_name":80,"name_similarity":81,"medical_device_id":82,"vector_similarity":18,"class_classification":69,"definition_similarity":83,"id":82,"category_code":31,"category_name":32,"subcategory_name":71,"data_exist":14,"product_count":46,"company_count":84,"market_size":85,"market_size_unit":48,"growth_ratio":16,"average_price":86,"average_price_unit":76,"domestic_ratio":16},0.0153846,"35591200","ブタ心臓弁",0.222222,197,0.184049,3,2.11,85.18,{"score":88,"jmdn_code":89,"generic_name":90,"name_similarity":91,"medical_device_id":92,"vector_similarity":18,"class_classification":93,"definition_similarity":94,"id":92,"category_code":95,"category_name":96,"subcategory_name":71,"data_exist":15,"product_count":18,"company_count":18,"market_size":18,"market_size_unit":18,"growth_ratio":18,"average_price":18,"average_price_unit":18,"domestic_ratio":18},0.0151515,"42526000","眼弁補綴材",0.194444,687,"Ⅲ",0.31,"医04","整形用品",{"score":98,"jmdn_code":99,"generic_name":100,"name_similarity":101,"medical_device_id":102,"vector_similarity":18,"class_classification":29,"definition_similarity":103,"id":102,"category_code":42,"category_name":43,"subcategory_name":44,"data_exist":15,"product_count":34,"company_count":17,"market_size":18,"market_size_unit":18,"growth_ratio":18,"average_price":18,"average_price_unit":18,"domestic_ratio":18},0.0149254,"70305009","シャントバルブプログラマ",0.216216,2050,0.122172,{"score":105,"jmdn_code":106,"generic_name":107,"name_similarity":108,"medical_device_id":109,"vector_similarity":18,"class_classification":93,"definition_similarity":110,"id":109,"category_code":42,"category_name":43,"subcategory_name":44,"data_exist":15,"product_count":18,"company_count":18,"market_size":18,"market_size_unit":18,"growth_ratio":18,"average_price":18,"average_price_unit":18,"domestic_ratio":18},0.0147059,"70315000","胸水シャントバルブ",0.2,422,0.176166,{"score":112,"jmdn_code":113,"generic_name":114,"name_similarity":115,"medical_device_id":116,"vector_similarity":18,"class_classification":93,"definition_similarity":117,"id":116,"category_code":42,"category_name":43,"subcategory_name":44,"data_exist":15,"product_count":18,"company_count":18,"market_size":18,"market_size_unit":18,"growth_ratio":18,"average_price":18,"average_price_unit":18,"domestic_ratio":18},0.0144928,"35965000","水頭症用バルブ補綴材",0.204545,423,0.144068,{"score":119,"jmdn_code":120,"generic_name":121,"name_similarity":122,"medical_device_id":123,"vector_similarity":18,"class_classification":58,"definition_similarity":124,"id":123,"category_code":31,"category_name":32,"subcategory_name":71,"data_exist":15,"product_count":34,"company_count":34,"market_size":18,"market_size_unit":18,"growth_ratio":18,"average_price":18,"average_price_unit":18,"domestic_ratio":18},0.0142857,"70482000","人工弁テスタ",0.179487,3915,0.282443,[],{"510k":127,"classification":128,"enforcement":129,"event":130,"event_backfill":131,"pma":132,"warning_letter":133},"2026-10-19T02:00:49.606+00:00","2026-10-19T02:00:41.111+00:00","2026-10-19T02:00:46.002+00:00","2026-10-20T04:00:55.31+00:00","2026-09-07T05:17:28.839+00:00","2026-10-19T02:00:50.583+00:00","2026-10-20T01:14:56.449+00:00",{"product_code":6,"device_name_ja":135,"definition_ja":136,"commentary_ja":137,"model_name":138,"source_hash":139,"reviewed_by":18,"reviewed_at":18,"created_at":140,"updated_at":140},"ポリマー製人工心臓弁","本品は心臓弁を置換することを目的とした永久的インプラントである。","本品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）の対象となる医療機器です。クラスIIIは人体へのリスクが最も高い区分とされ、有効性と安全性に関する科学的な審査を経たうえで承認される必要があります。","claude-sonnet-5","12d43341f4ba131a8bda0862667c4780ceb3eaafc13bb0e521304193c7b5a050","2026-10-20T05:28:58.126024+00:00",{"items":142,"total":16},[],{"items":144,"total":16},[],{"items":146,"total":17},[147],{"pma_number":148,"supplement_number":10,"trade_name":149,"applicant":150,"decision_date":151},"P260007","Autus Size-Adjustable Valve","Edwards Lifesciences, LLC","2026-10-01"]