{"schema_version":"secwatch.filing_event.v1","accession":"0001688757-24-000067","form_type":"8-K","ticker":"ESTA","cik":"0001688757","company_name":"ESTABLISHMENT LABS HOLDINGS INC.","filed_at":"2024-07-16T23:59:59+00:00","discovered_at":"2026-05-14T18:03:14.116471+00:00","generated_at":"2026-05-31T20:31:10.709146+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.3,"calibrated_materiality_score":0.3,"confidence":"high","headline":"FDA PMA preapproval inspection of Establishment Labs' Motiva Implant facility rescheduled to July 22","bullets":["FDA will begin PMA preapproval inspection of Motiva Implants manufacturing facility on July 22, 2024.","Inspection was previously scheduled for the first week of July 2024.","Rescheduling is a procedural update; no new findings or delays beyond the date change."],"urls":{"canonical":"https://secwatch.observer/filing/0001688757-24-000067","json":"https://secwatch.observer/filing/0001688757-24-000067.json","markdown":"https://secwatch.observer/filing/0001688757-24-000067.md","text":"https://secwatch.observer/filing/0001688757-24-000067.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1688757/000168875724000067/0001688757-24-000067-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1688757/000168875724000067/esta-20240716.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T20:31:10.709146+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"}