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