Surmodics Gets FDA Request for Clarification of SurVeil Drug-Coated Balloon [MarketWatch]
Surmodics, Inc. (SRDX)
Last surmodics, inc. earnings: 4/29 04:05 pm
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Source: MarketWatch
Food and Drug Administration related to its proposed approach to submit an amended premarket approval application for the SurVeil drug-coated balloon. Following the receipt of the FDA letter in January, Surmodics said it has been focused on obtaining additional clarification and feedback on the pathway and requirements to submit an amended premarket approval application for the SurVeil DCB in an approvable form. 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 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 th
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