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FR 43621に基づき、1989年3月1日までにPMAを提出することを求める。","この製品コードは、脳の深部または皮質下領域を電気刺激する目的で体内に植え込まれる刺激装置に関するものです。米国ではクラスIIIに分類されており、市販前承認（PMA）による審査が必要とされています。これは、有効性および安全性を科学的根拠に基づき包括的に評価する、米国で最も厳格な審査区分です。","claude-sonnet-5","9878e1acd5ed0d5e62de8263fdcd0e568d8fa5a11a650c9bab75d03b25d9e11c","2026-08-24T01:55:21.85667+00:00",{"product_code":6,"summary_ja":128,"stats":129,"stats_hash":144,"model_name":124,"created_at":145,"updated_at":145},"不具合報告は累計約70件で、死亡2件、傷害約30件、不具合（Malfunction）約10件となっており、死亡・傷害の合計が不具合件数を上回る内訳です。主な問題としてAmbient Noise Problem（周囲雑音の問題）が報告されています。直近5年間の報告は1件で、最新の報告は2023年8月です。回収は確認されていません。",{"pma":130,"k510":131,"as_of":132,"events":133,"recalls":140,"top_problems":142},{"latest":25,"originals":24,"supplements":24},{"total":24,"last5y":24,"latest":25,"applicants":24},"2026-08",{"death":134,"other":135,"total":26,"injury":136,"last5y":137,"malfunction":138,"latest_month":139},2,27,31,1,13,"2023-08",{"total":24,"last5y":24,"latest":25,"class_i":24,"class_ii":24,"class_iii":24,"top_root_causes":141},[],[143],"Ambient Noise Problem","813b9535d7de9cc2b16913987214e874828bf2999606fd5310be9d62d7d0df96","2026-08-24T04:30:57.116764+00:00",{"items":147,"total":24},[],{"items":149,"total":24},[],{"items":151,"total":24},[]]