Surmodics Takes a Second Swing at FDA Approval

Surmodics struck out on its first attempt to win FDA approval for the highly-anticipated SurVeil drug-coated balloon when the company received a letter from the agency that its premarket approval (PMA) application for the device was not approvable. The Eden Prairie, MN-based company submitted an amended PMA application in May, however, and this second swing just might be the home run investors have been hoping for.