---
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"
generated_at: "2026-05-31T20:31:10.709146+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.3
calibrated_materiality_score: 0.3
confidence: "high"
source: SEC EDGAR
---

# FDA PMA preapproval inspection of Establishment Labs' Motiva Implant facility rescheduled to July 22

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.3
- calibrated_materiality_score: 0.3
- confidence: high
- sec_items: 8.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001688757-24-000067
- JSON: https://secwatch.observer/filing/0001688757-24-000067.json
- Plain text: https://secwatch.observer/filing/0001688757-24-000067.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.