SurModics (SRDX) Sundance Sirolimus-Coated Balloon Catheter Earns FDA Breakthrough Device Status

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Go back to SurModics (SRDX) Sundance Sirolimus-Coated Balloon Catheter Earns FDA Breakthrough Device Status

The Surmodics Sundance™ Sirolimus-Coated Balloon Catheter Earns FDA Breakthrough Device Status

October 29, 2019 8:30 AM EDT

Sundance Sirolimus-Coated Balloon will receive prioritization throughout the FDA submission and review process to provide patients and physicians timely access to medical devices

EDEN PRAIRIE, Minn.--(BUSINESS WIRE)-- Surmodics, Inc. (NASDAQ: SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced that the United States Food and Drug Administration (FDA) has designated its Sundance sirolimus-coated balloon (SCB) catheter as a Breakthrough Device under the Agencys Breakthrough Devices Program.

The program, launched in December 2018, is designed to streamline the... More