By BRAD PERRIELLO
MassDevice.com

WARSAW — Medtronic said Tuesday, Sept. 15, that the FDA granted pre-market approval for its Evera MRI SureScan device, touting it as the first MRI-safe implantable cardiac defibrillator to win U.S. approval.

Fridley, Minn.-based Medtronic said the Evera device is approved for MRI scans of any body area. The device is expected to hit the market this month, including the ICD itself and Medtronic’s Sprint Quattro Secure MRI SureScan DF4 leads, which are required for the MRI-safe designation.

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