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Description

Therefore, the SCOUT MD TM Surgical Guidance System meets the criterion at 419.66(c)(2)(ii) and is not evaluated for substantial clinical improvement at 419.66(c)(2)(i)

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Whereas irreversible injury manifests after frank loss of neuronal tissue has occurred

Grading and causality The severity of each AE will be graded by the investigator according to the National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) v6.0 criteria