Surmodics (Nasdaq:SRDX) announced today that it received formal feedback from the FDA related to its SurVeil drug-coated balloon (DCB).
Eden Prairie, Minnesota-based Surmodics gave the FDA a proposed approach to submit an amended premarket approval application for SurVeil. In January, the FDA indicated that Surmodics’ SurVeil PMA application is not approvable.
The FDA said it declined to approve SurVeil due to certain information in the biocompatibility and labeling categories. The governing agency said more information needs to be added by an amendment to the PMA application to place it in an approvable form. Just weeks later, Surmodics laid off around 60 employees as part of a restructuring effort.
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