{"filing":{"accession_number":"0001104659-26-065180","cik":"0002006986","ticker":"ADGM","company_name":"Adagio Medical Holdings, Inc.","form":"8-K","filing_date":"2026-05-21","report_date":null,"primary_document":"tm2614299d2_8k.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/2006986/000110465926065180/tm2614299d2_8k.htm"},"events":[{"id":9339,"run_id":8192,"accession_number":"0001104659-26-065180","anchor_item_number":"8.01","event_type":"other_material","event_domain":"catchall","is_material":true,"confidence":0.85,"summary":"Adagio Medical submitted a Premarket Approval (PMA) application to the FDA for its vCLAS® Ventricular Ablation System, a significant regulatory milestone for a medical device company. This event is material to investors as FDA approval is a critical path to commercialization and revenue generation, but it does not fit neatly into the more specific event categories (not an earnings release, M\u0026A activity, impairment, litigation, or other defined types). The submission of a major regulatory application represents a material corporate development warranting disclosure under Item 8.01.","company_name":"Adagio Medical Holdings, Inc.","ticker":"ADGM","filing_date":"2026-05-21","form":"8-K","submitted_at":null,"items":[{"id":944,"accession_number":"0001104659-26-065180","item_number":"8.01","item_title":"Other Events","event_type":"other_material","event_domain":"catchall","is_material":true,"confidence":0.85,"reasoning":"Adagio Medical submitted a Premarket Approval (PMA) application to the FDA for its vCLAS® Ventricular Ablation System, a significant regulatory milestone for a medical device company. This event is material to investors as FDA approval is a critical path to commercialization and revenue generation, but it does not fit neatly into the more specific event categories (not an earnings release, M\u0026A activity, impairment, litigation, or other defined types). The submission of a major regulatory application represents a material corporate development warranting disclosure under Item 8.01.","classifier_version":"claude-haiku-4-5-20251001+prompt-9e0ffca5","taxonomy_version":"v1","classified_at":"2026-05-22T02:33:26.261347+00:00","company_name":"","ticker":null,"filing_date":""}]}],"classifications":[{"id":944,"accession_number":"0001104659-26-065180","item_number":"8.01","item_title":"Other Events","event_type":"other_material","event_domain":"catchall","is_material":true,"confidence":0.85,"reasoning":"Adagio Medical submitted a Premarket Approval (PMA) application to the FDA for its vCLAS® Ventricular Ablation System, a significant regulatory milestone for a medical device company. This event is material to investors as FDA approval is a critical path to commercialization and revenue generation, but it does not fit neatly into the more specific event categories (not an earnings release, M\u0026A activity, impairment, litigation, or other defined types). The submission of a major regulatory application represents a material corporate development warranting disclosure under Item 8.01.","classifier_version":"claude-haiku-4-5-20251001+prompt-9e0ffca5","taxonomy_version":"v1","classified_at":"2026-05-22T02:33:26.261347+00:00","company_name":"Adagio Medical Holdings, Inc.","ticker":"ADGM","filing_date":"2026-05-21"}]}