Product analysis for the generator was completed.Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was successfully verified in the product analysis (pa) lab.In the pa lab, the device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment and showed no signs of variation in output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.In addition, a comprehensive automated electrical evaluation showed that the device performed according to functional specifications.There were no performance or any other type of adverse condition found with the pulse generator.No additional or relevant information has been received to date.
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