On May 8, 1996, you submitted an _____ for studies of _____ using an _____ (_____ hereafter “_____”). By letter dated June 7, 1996, (the _____ letter), FDA approved your _____ Under the _____ you may perform _____ to treat _____ for 300 patients at one institution. FDA also requested in the _____ approval letter that, within 45 days, you respond to a list of deficiencies regarding your _____ including a request that you submit information regarding “aspects of your device hardware, firmware, and software which mitigate against device failure and ensure adequate calibration of its output.”