premarket approval
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Regulatory
MCRA CRO Assists Simplify Medical, Inc. on the Fastest Spine PMA Ever Approved by the FDA
WASHINGTON, Oct. 1, 2020 /PRNewswire/ — MCRA, LLC, a leading medical device and biologics advisory firm and Clinical Research Organization (CRO) integrating U.S.…
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Hospitals
New US FDA guidance: Six benefit-risk factors to include in medical device IDE applications
By Stewart Eisenhart In an effort to boost predictability and transparency of its Investigational Device Exemption (IDE) review process, the…
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MCRA Assists VertiFlex, Inc. with Obtaining FDA PMA Approval for the Superion® Interspinous Spacer System
WASHINGTON, June 24, 2015 /PRNewswire-USNewswire/ — Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) announced today its role in the successful Premarket Approval (PMA) application…
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