{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-11-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Ineligible",
      "product_code": "MXM",
      "openfda": {
        "pma_number": [
          "P040025"
        ]
      },
      "review_panel": "NE",
      "medical_specialty": "",
      "device_name": "Cap, Cooling (Infants)",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Unknown",
      "device_class": "3",
      "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.",
      "regulation_number": "",
      "implant_flag": "N",
      "submission_type_id": "2"
    }
  ]
}