[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-LWW":3},{"classification":4,"mappedDevices":28,"similarCandidates":29,"relatedClassifications":102,"syncDates":103,"translation":110,"marketSummary":116,"recalls":138,"k510s":140,"pmas":142},{"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":9,"implant_flag":13,"life_sustain_support_flag":13,"gmp_exempt_flag":13,"raw":14,"created_at":22,"updated_at":23,"recall_count":24,"latest_recall_date":25,"k510_count":24,"pma_count":26,"event_count":27},20,"LWW","Pulse-Generator, Single Chamber, Single","3","","Unknown","CV","2",false,{"openfda":15,"definition":9,"device_name":7,"review_code":9,"device_class":8,"implant_flag":20,"product_code":6,"review_panel":11,"gmp_exempt_flag":20,"third_party_flag":20,"medical_specialty":9,"regulation_number":9,"submission_type_id":12,"unclassified_reason":9,"life_sustain_support_flag":20,"medical_specialty_description":10,"summary_malfunction_reporting":21},{"pma_number":16},[17,18,19],"P820022","P860007","P850027","N","Ineligible","2026-08-18T05:52:47.660896+00:00","2026-08-24T02:00:48.095002+00:00",0,null,36,19,[],[30,38,46,54,61,68,76,82,89,95],{"medical_device_id":31,"generic_name":32,"class_classification":33,"jmdn_code":34,"name_similarity":35,"definition_similarity":24,"vector_similarity":36,"score":37},3340,"単回使用パルスオキシメータプローブ","Ⅰ","31658000",0.297872,0.672934,0.0295139,{"medical_device_id":39,"generic_name":40,"class_classification":41,"jmdn_code":42,"name_similarity":43,"definition_similarity":24,"vector_similarity":44,"score":45},2449,"単回使用酸素発生式供給器","Ⅱ","70581000",0.283019,0.676633,0.029236,{"medical_device_id":47,"generic_name":48,"class_classification":49,"jmdn_code":50,"name_similarity":51,"definition_similarity":24,"vector_similarity":52,"score":53},731,"人工心肺用拍動圧ジェネレータ","Ⅲ","35101000",0.241935,0.680791,0.0282194,{"medical_device_id":55,"generic_name":56,"class_classification":49,"jmdn_code":57,"name_similarity":58,"definition_similarity":24,"vector_similarity":59,"score":60},1181,"単回使用ガス式肺人工蘇生器","57981003",0.245902,0.664844,0.0267094,{"medical_device_id":62,"generic_name":63,"class_classification":49,"jmdn_code":64,"name_similarity":65,"definition_similarity":24,"vector_similarity":66,"score":67},777,"単回使用手動式肺人工蘇生器","36086000",0.238806,0.65021,0.0245215,{"medical_device_id":69,"generic_name":70,"class_classification":71,"jmdn_code":72,"name_similarity":73,"definition_similarity":24,"vector_similarity":74,"score":75},273,"除細動機能なし植込み型両心室ペーシングパルスジェネレータ","Ⅳ","70515000",0.195652,0.74928,0.0163934,{"medical_device_id":77,"generic_name":78,"class_classification":33,"jmdn_code":79,"name_similarity":80,"definition_similarity":24,"vector_similarity":81,"score":75},3931,"単回使用汎用ウォータトラップ","41679000",0.333333,0.552944,{"medical_device_id":83,"generic_name":84,"class_classification":71,"jmdn_code":85,"name_similarity":86,"definition_similarity":24,"vector_similarity":87,"score":88},200,"植込み型心臓ペースメーカ","12913000",0.0701754,0.734915,0.016129,{"medical_device_id":90,"generic_name":91,"class_classification":41,"jmdn_code":92,"name_similarity":93,"definition_similarity":24,"vector_similarity":94,"score":88},2855,"単回使用穿孔器","12989002",0.325,0.618096,{"medical_device_id":96,"generic_name":97,"class_classification":71,"jmdn_code":98,"name_similarity":99,"definition_similarity":24,"vector_similarity":100,"score":101},272,"除細動機能付植込み型両心室ペーシングパルスジェネレータ","70514000",0.202247,0.732946,0.015873,[],{"510k":104,"classification":105,"enforcement":106,"event":107,"pma":108,"warning_letter":109},"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":111,"definition_ja":25,"commentary_ja":112,"model_name":113,"source_hash":114,"reviewed_by":25,"reviewed_at":25,"created_at":115,"updated_at":115},"単一チャンバ式パルスジェネレータ（単発型）","本品は米国FDAの規制上クラスIIIに分類される医療機器であり、市販前承認（PMA）による審査対象となっています。クラスIIIはFDAの医療機器分類の中で最も規制が厳しい区分であり、人体への高いリスクを伴う機器や、有効性・安全性の実証に十分な科学的根拠が必要な機器が該当し、510(k)による市販前届出ではなく、より詳細な臨床データの提出を伴うPMA審査が要求されます。","claude-sonnet-5","8c0d94138a1f2668cdfe3f5393200e7f6f0d9b5224ced82822b1df9a4f9c121c","2026-08-24T02:13:33.96397+00:00",{"product_code":6,"summary_ja":117,"stats":118,"stats_hash":136,"model_name":113,"created_at":137,"updated_at":137},"本製品は PMA（市販前承認）区分の機器であり、本承認が3件、一部変更承認が33件、最新の判定は2012年4月となっています。不具合報告は累計約20件で、死亡が1件、傷害が約10件、不具合（Malfunction）が約10件と、死亡・傷害の報告が多くを占めており、直近5年では約8件、最新の報告月は2026年4月です。主な問題としては、Premature Discharge of Battery（電池の早期放電）、Battery Problem（電池の問題）、High impedance（インピーダンス上昇）が挙げられています。回収については累計件数が確認されていません。",{"pma":119,"k510":123,"as_of":124,"events":125,"recalls":130,"top_problems":132},{"latest":120,"originals":121,"supplements":122},"2012-04-23",3,33,{"total":24,"last5y":24,"latest":25,"applicants":24},"2026-08",{"death":126,"other":24,"total":27,"injury":127,"last5y":128,"malfunction":128,"latest_month":129},1,10,8,"2026-04",{"total":24,"last5y":24,"latest":25,"class_i":24,"class_ii":24,"class_iii":24,"top_root_causes":131},[],[133,134,135],"Premature Discharge of Battery","Battery Problem","High impedance","3bbcca4871084c4b9ce230c43507f8ded90f66e23e28ed9c4795d022047adb3b","2026-08-24T04:52:46.442187+00:00",{"items":139,"total":24},[],{"items":141,"total":24},[],{"items":143,"total":26},[144,148,151,154,157,160,162,166,170,173,177,181,184,187,190,192,195,199,203,207],{"pma_number":18,"supplement_number":145,"trade_name":146,"applicant":147,"decision_date":120},"S024","INTERTACH","Boston Scientific",{"pma_number":17,"supplement_number":149,"trade_name":150,"applicant":147,"decision_date":120},"S005","CYBERTACH PULSE GENERATOR SYSTEM",{"pma_number":18,"supplement_number":152,"trade_name":146,"applicant":147,"decision_date":153},"S023","2004-12-22",{"pma_number":17,"supplement_number":155,"trade_name":156,"applicant":147,"decision_date":153},"S004","CYBERTACH",{"pma_number":18,"supplement_number":158,"trade_name":146,"applicant":147,"decision_date":159},"S022","2004-11-19",{"pma_number":17,"supplement_number":161,"trade_name":156,"applicant":147,"decision_date":159},"S003",{"pma_number":18,"supplement_number":163,"trade_name":164,"applicant":147,"decision_date":165},"S021","IMPLANTABLE PACEMAKER LEADS","1999-12-02",{"pma_number":18,"supplement_number":167,"trade_name":168,"applicant":147,"decision_date":169},"S020","INTERTACH II MODELS 262-16","1998-07-06",{"pma_number":18,"supplement_number":171,"trade_name":168,"applicant":147,"decision_date":172},"S018","1996-08-19",{"pma_number":18,"supplement_number":174,"trade_name":175,"applicant":147,"decision_date":176},"S016","INTERTACH(R) FAMILY OF PULSE GENERATORS","1996-05-21",{"pma_number":18,"supplement_number":178,"trade_name":179,"applicant":147,"decision_date":180},"S017","INTERTACH(R)II MODELS 262-16","1996-03-22",{"pma_number":18,"supplement_number":182,"trade_name":179,"applicant":147,"decision_date":183},"S015","1995-03-01",{"pma_number":18,"supplement_number":185,"trade_name":179,"applicant":147,"decision_date":186},"S011","1995-01-18",{"pma_number":18,"supplement_number":188,"trade_name":179,"applicant":147,"decision_date":189},"S014","1994-05-17",{"pma_number":18,"supplement_number":191,"trade_name":179,"applicant":147,"decision_date":189},"S013",{"pma_number":18,"supplement_number":193,"trade_name":179,"applicant":147,"decision_date":194},"S012","1993-08-04",{"pma_number":18,"supplement_number":196,"trade_name":197,"applicant":147,"decision_date":198},"S010","INTERTACH(R)II MODELS 262-16\u002F262-16R DISCON.TEST","1993-01-11",{"pma_number":18,"supplement_number":200,"trade_name":201,"applicant":147,"decision_date":202},"S009","INTERTACH(R)II & RX2000(R) GRAPHICS PROGRAM MODULE","1992-12-29",{"pma_number":18,"supplement_number":204,"trade_name":205,"applicant":147,"decision_date":206},"S008","INTERTACH & INTERTACH II PULSE GENERATORS","1992-03-03",{"pma_number":18,"supplement_number":208,"trade_name":205,"applicant":147,"decision_date":209},"S006","1991-11-19"]