{"schema_version":"secwatch.filing_event.v1","accession":"0001688757-24-000042","form_type":"8-K","ticker":"ESTA","cik":"0001688757","company_name":"ESTABLISHMENT LABS HOLDINGS INC.","filed_at":"2024-04-02T23:59:59+00:00","discovered_at":"2026-05-14T18:03:19.588301+00:00","generated_at":"2026-06-04T03:38:23.066333+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"FDA schedules PMA preapproval inspection of Establishment Labs' Motiva Implants facility in Q2 2024","bullets":["FDA schedules PMA preapproval inspection of Motiva Implants manufacturing facility for Q2 2024.","Inspection is a required step in the premarket approval (PMA) process for U.S. market entry.","Announcement made on April 2, 2024 during J.P. Morgan MedTech CEO Conference."],"urls":{"canonical":"https://secwatch.observer/filing/0001688757-24-000042","json":"https://secwatch.observer/filing/0001688757-24-000042.json","markdown":"https://secwatch.observer/filing/0001688757-24-000042.md","text":"https://secwatch.observer/filing/0001688757-24-000042.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1688757/000168875724000042/0001688757-24-000042-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1688757/000168875724000042/esta-20240402.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-04T03:38:23.066333+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}