---
schema_version: "secwatch.filing_event.v1"
accession: "0001688757-24-000065"
form_type: "8-K"
ticker: "ESTA"
cik: "0001688757"
company_name: "ESTABLISHMENT LABS HOLDINGS INC."
filed_at: "2024-06-05T23:59:59+00:00"
generated_at: "2026-06-01T06:17:58.199753+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# FDA deems Establishment Labs' Motiva Implants PMA approvable pending facility inspection

## Summary
- FDA CDRH completed PMA review for Motiva Implants; says PMA is approvable subject to acceptable manufacturing facility inspection.
- FDA inspection of manufacturing facilities rescheduled from prior dates to occur within next 30 days.
- Announced June 5, 2024 at Jefferies Global Healthcare Conference.

## SEC filing metadata
- accession: 0001688757-24-000065
- form_type: 8-K
- ticker: ESTA
- cik: 0001688757
- company_name: ESTABLISHMENT LABS HOLDINGS INC.
- filed_at: 2024-06-05T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1688757/000168875724000065/0001688757-24-000065-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1688757/000168875724000065/esta-20240605.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001688757-24-000065
- JSON: https://secwatch.observer/filing/0001688757-24-000065.json
- Plain text: https://secwatch.observer/filing/0001688757-24-000065.txt

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