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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
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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