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

ESTABLISHMENT LABS HOLDINGS INC.

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.

item 8.01

ESTABLISHMENT LABS HOLDINGS INC. filing history →

Source: SEC EDGAR

accession 0001688757-24-000042

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