Robert A. Herrmann reposted this
MCRA is pleased to announce its role in the successful Premarket Approval (PMA) application decision by the U.S. Food and Drug Administration (FDA) to approve the SurVeil™ drug-coated balloon (DCB) to treat peripheral artery disease (PAD). MCRA’s Regulatory and Biocompatibility experts collaborated closely, enabling MCRA to both develop the robust technical discussions and then articulate them to FDA in terms of safety, effectiveness and favorable benefit-risk profile. Read the full press release on our website now. Surmodics, Inc. #mcra #pma #cardiovascular #medtech #biocompatibility #fda #medicaldevices #news