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Medical Devices / Submissions and Approvals

EU Grants CE Mark to St. Jude Medical’s Full Body MR Conditional Labeling for the Proclaim Elite System

Dec. 9, 2016

St. Jude Medical earned the CE mark for the full-body magnetic resonance conditional labeling of its Proclaim Elite spinal cord stimulation system.

With this label approval, the device, which is intended to reduce chronic pain, is authorized for use in full-body magnetic resonance imaging diagnostic scans.

The FDA approved expanded labeling for the device in November.  — Cynthia Jessup

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