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50708に基づき、1996年12月26日までにPMAを提出するよう求める。","この機器は米国FDAによりクラスIIIに分類されており、市販前にPMA（市販前承認）による審査を受けることが求められています。クラスIIIは人の生命や健康に重大な影響を及ぼしうる機器に適用される最も規制の厳しい区分であり、有効性と安全性を裏付ける十分な科学的データの提出が必要とされます。上記の官報告示は、既に流通していた当該機器について、PMA申請書類を所定の期限までに提出するよう求めたものです。","claude-sonnet-5","60d8103eed30bfe1e0dc5f7569ddb03d0e1ab1e867b5424216099437df6c4e43","2026-08-24T01:55:21.85667+00:00",{"product_code":6,"summary_ja":124,"stats":125,"stats_hash":136,"model_name":120,"created_at":137,"updated_at":137},"本製品コードでは、510(k)およびPMAのいずれについても承認・届出の実績は確認されていません。不具合報告（MDR）は累計3件で、内訳は死亡1件、不具合（Malfunction）2件となっており、直近5年間の報告はなく、最新の報告は1992年7月となっています。回収（リコール）については、クラスI・II・IIIのいずれも件数は確認されていません。",{"pma":126,"k510":127,"as_of":128,"events":129,"recalls":133,"top_problems":135},{"latest":23,"originals":22,"supplements":22},{"total":22,"last5y":22,"latest":23,"applicants":22},"2026-08",{"death":130,"other":22,"total":24,"injury":22,"last5y":22,"malfunction":131,"latest_month":132},1,2,"1992-07",{"total":22,"last5y":22,"latest":23,"class_i":22,"class_ii":22,"class_iii":22,"top_root_causes":134},[],[],"be2d72ef941e8dfba828fb7bb656cae3019de863300eeeeab669d58c0385fa17","2026-08-24T04:32:35.506862+00:00",{"items":139,"total":22},[],{"items":141,"total":22},[],{"items":143,"total":22},[]]