Allurion Announces Submission of First Three Modules of Premarket Approval Application to the U.S. Food and Drug Administration for the Allurion Balloon
Allurion Technologies, Inc. (ALUR)
Company Research
Source: Business Wire
NATICK, Mass.--(BUSINESS WIRE)--Allurion Technologies, Inc. (NYSE: ALUR), a company dedicated to ending obesity, today announced the submission of the first three modules of its premarket approval application (PMA) to the U.S. Food and Drug Administration (FDA) for the Allurion Balloon. The Company expects to file the fourth and final module of the PMA containing the clinical data from its AUDACITY trial early next year."These submissions are a critical milestone for Allurion, and I commend our team for their efforts," said Dr. Shantanu Gaur, Allurion’s Founder and CEO. "We are pleased to capitalize on the opportunity that the FDA provides through its modular submission program to improve the efficiency of our application process."In a traditional PMA application, the applicant submits all PMA data at the same time, and the FDA begins its PMA review only upon receipt of all of the required information. In a modular PMA application, the FDA allows applicants to submit discrete sect
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Earnings
- 11/13/24 - Beat
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Sec Filings
- 12/23/24 - Form EFFECT
- 12/20/24 - Form POS
- 12/19/24 - Form 424B3
- ALUR's page on the SEC website