483
Medtronic Navigation, Inc.-BoxboroughMedtronic Navigation, Inc.-Boxborough – FDA 483, Jun 11, 2024
Record Details
An FDA inspection of Medtronic Navigation, Inc.-Boxborough identified two significant compliance issues. The firm failed to submit Medical Device Reports (MDRs) within the required 30-day timeframe for several device malfunctions. Additionally, device history records for the O-Arm O2 Imaging System were not adequately maintained, lacking essential safety labeling.
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