{
  "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": "2026-08-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "Y",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Eligible",
      "product_code": "OIR",
      "openfda": {
        "pma_number": [
          "P200018"
        ],
        "registration_number": [
          "3009183442",
          "1526534",
          "3005868392"
        ],
        "fei_number": [
          "3009183442",
          "1526534",
          "3005868392"
        ]
      },
      "review_panel": "AN",
      "medical_specialty": "",
      "device_name": "Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Unknown",
      "device_class": "3",
      "definition": "The device is intended for use in patients with stable, high spinal cord injuries with stimulatable diaphragms, but who lack control of their diaphragms. The device is indicated to allow the patients to breathe without the assistance of a mechanical ventilator for at least 4 continuous hours a day.  For use only in patients 18 years of age or older.",
      "regulation_number": "",
      "implant_flag": "Y",
      "submission_type_id": "2"
    }
  ]
}