The FDA's Center For Devices And Radiological Health Has Completed Review Of Establishment Labs' Premarket Approval Application For Motiva Implants And Says The Application Is Approvable Subject To An Acceptable FDA Inspection Of Manufacturing Facilities
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The FDA's Center for Devices and Radiological Health has completed its review of Establishment Labs' premarket approval application for Motiva Implants. The application is deemed approvable pending an acceptable FDA inspection of the manufacturing facilities, which has been rescheduled to occur within the next thirty days.
June 05, 2024 | 11:13 am
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The FDA has completed its review of Establishment Labs' premarket approval application for Motiva Implants, deeming it approvable pending an FDA inspection of the manufacturing facilities within the next thirty days.
The FDA's completion of the review and the conditional approval is a positive development for Establishment Labs. The pending inspection, if successful, will likely lead to final approval, which could boost the company's stock price.
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