Surmodics Provides Regulatory Update on its Strategy to Submit an Amended Premarket Approval Application for the SurVeil™ Drug-Coated Balloon

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Mar 28, 2023

Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced that it has received formal feedback from the Food and Drug Administration (FDA; the Agency) related to its proposed approach to submit an amended premarket approval (PMA) application for the SurVeil™ drug-coated balloon (DCB).