Medical device company Mainstay Medical International has submitted a Pre-Investigational Device Exemption information package to the FDA for its implantable neurostimulation device ReActiv8.
Under the submission, the device company can seek FDA feedback on its planned submission of an Investigational Device Exemption. Feedback could include comment on proposed study design or statistical analysis plan.
The ReActiv8 is designed for the treatment of chronic lower back pain.
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