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Home » FDA Calls for More Details Before Approving Surmodics’ Drug-Coated Balloon
FDA Calls for More Details Before Approving Surmodics’ Drug-Coated Balloon
The FDA has sent Surmodics a Complete Response Letter for its SurVeil drug-coated balloon, asking the company to amend its premarket approval application (PMA) to add information on biocompatibility and labeling.