Drug Delivery Business

Surmodics targets FDA premarket approval for drug-coated balloon in Q4

By

SurModicsSurmodics (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.

Get the full story at our sister site, Medical Tubing & Extrusion.

IN CASE YOU MISSED IT

About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at swhooley@wtwhmedia.com.