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If none are applicable leave the checkboxes blank and continue to section C. The use of the Humanitarian Use Device is permanently closed to enrollment. Benefits experienced by patients. others. summary of the numbers of withdrawals/terminations and their reasons. Copy of FDA s HDE approval. A description of the device. The product labeling. The patient information packet that may accompany the HUD. If any change is being requested at the time of continuing review submit a HRP-222...
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