Surmodics receives FDA feedback on strategy to submit amended PMA for SurVeil

Surmodics announced that it has received formal feedback from the Food and Drug Administration, FDA, related to its proposed approach to submit an amended premarket approval, PMA, application for the SurVeil drug-coated balloon, DCB. Following the receipt of the FDA letter announced in the company’s press release on January 19th, Surmodics has been focused on obtaining additional clarification and feedback from the Agency on the pathway and requirements to submit an amended PMA application for the SurVeil DCB in an approvable form. To this end, Surmodics prepared and submitted a Submission Issue Request, under the FDA’s Q-Submission Program, to obtain the Agency’s formal feedback on its proposed approach for addressing the FDA letter. The company has received written feedback from the FDA in response to its Submission Issue Request and completed a Submission Issue Meeting with the Agency to discuss the request and this written feedback. In its verbal and written feedback, the FDA requested additional clarification related to already completed biocompatibility studies and revisions to the company’s proposed labeling to amend the PMA application to put it into an approvable form. The FDA noted that the feedback it provided was based on the level of information included in the company’s Submission Issue Request, and that the actual determination for the acceptability of the company’s responses will depend on the information provided in company’s formal amended PMA application to be filed with the FDA.