FDA Approval Process Begins for Motiva Breast Implants
/Establishment Labs has begun the process of gaining FDA approval by submitting an Investigational Device Exemption (IDE) filing to the U.S. Food and Drug Administration (FDA) for its Motiva Implants®. Upon acceptance, the IDE would enable the Company to initiate a clinical study in the U.S. to assess the safety profile and patient satisfaction of Motiva Implants.
Juan José Chacón-Quirós, CEO and founder of Establishment Labs said “Motiva Implants are already sold in over 60 countries worldwide and have been implanted more than 300,000 times over the past seven years. We are confident that a clinical study in the United States will confirm the safety profile we are seeing in all of our markets.”
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