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

ESTABLISHMENT LABS HOLDINGS INC.

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.

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