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Sapheon, Inc. Submits Second Module Of PMA Application For VenaSeal® Sapheon Closure System; Raises $10M In Bridge Note Financing


1/7/2014 9:22:32 AM

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MORRISVILLE, N.C.--(BUSINESS WIRE)--Sapheon Inc. announced today that it has submitted the second module of the pre-market approval (PMA) application for the VenaSeal® Sapheon Closure System to the U.S. Food and Drug Administration (FDA). The submission, which was completed on December 18, 2013, represents steady progress on the modular PMA application for VenaSeal, a minimally invasive, single use kit intended for the treatment of venous reflux (varicose veins) disease. The first module, submitted in September 2013, was reviewed by the FDA and accepted without deficiencies within a single review cycle.

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