---
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"
generated_at: "2026-06-04T03:38:23.066333+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# FDA schedules PMA preapproval inspection of Establishment Labs' Motiva Implants facility in Q2 2024

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001688757-24-000042
- JSON: https://secwatch.observer/filing/0001688757-24-000042.json
- Plain text: https://secwatch.observer/filing/0001688757-24-000042.txt

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