Home » Medtronic Gets Hefty Warning From Preapproval Inspection for MiniMed
Medtronic Gets Hefty Warning From Preapproval Inspection for MiniMed
Medtronic was slapped with a 15-citation warning letter following a preapproval inspection for its MiniMed 530G continuous glucose monitoring system. The letter was posted online just days after the FDA approved the MiniMed, a first-generation artificial pancreas system with Threshold Suspend automation for diabetes patients.
Devices & Diagnostics Letter
Devices & Diagnostics Letter
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