Surmodics Gets FDA’s Feedback on Rejected PMA

Surmodics has received feedback from the FDA regarding the company’s plan to file an amended premarket approval (PMA) application for its SurVeil drug-coated balloon candidate for treatment of peripheral artery disease.

In January, the FDA said it could not approve the original PMA submission because of missing biocompatibility and labeling information.

The agency called for additional testing and analysis but “did not question the human clinical data submitted nor request any further human clinical data,” the company said.

Surmodics has now completed the requested biocompatibility studies and plans to submit the amended PMA application.