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U.S. Department of Health and Human Services

Product Classification

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Device cap,cooling (infants)
Definition Indicated for use in full-term infants with clinical evidence of moderate to severe hypoxic-ischemic encephalopathy (hie)*.Provides selective head cooling with mild systemic hypothermia to prevent or reduce the severity of neurologic injury associated with hie.
Review Panel Neurology
Product CodeMXM
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Neurodiagnostic and Neurosurgical Devices Branch (NNDB)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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