Maharaj continued, “Importantly, we do not anticipate the need for additional biocompatibility studies, which will significantly reduce our initial assumptions of the time and cost to amend our PMA application. The feedback from the FDA provides the necessary clarity on the process and content required to successfully amend our PMA application.” Gary Maharaj, CEO of Surmodics, stated in the company’s press release, “We are delighted with our progress toward achieving a PMA for the SurVeil DCB. The FDA advised the company that the feedback it provided was based on the level of information included in the company’s SIR 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.
The company has received written feedback from the FDA in response to the SIR and completed a Submission Issue Meeting with the agency to discuss the request and this written feedback.Īccording to Surmodics, 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. Surmodics advised it submitted a Submission Issue Request (SIR), under the FDA’s Q-Submission Program, to obtain the agency’s formal feedback on its proposed approach for addressing the FDA letter. This comes after the company’s announcement on January 19 that it received an FDA letter indicating that its PMA application was not approvable at that time, and the FDA provided specific guidance for a path forward. announced that it has received formal feedback from the FDA related to its proposed approach to submit an amended premarket approval (PMA) application for the SurVeil drug-coated balloon (DCB).
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