{
  "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": "2026-10-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "Y",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Ineligible",
      "product_code": "OVJ",
      "openfda": {
        "pma_number": [
          "P950037"
        ],
        "registration_number": [
          "9610139",
          "3033257494",
          "1028232"
        ],
        "fei_number": [
          "3002806500",
          "3033257494",
          "1028232"
        ]
      },
      "review_panel": "CV",
      "medical_specialty": "CV",
      "device_name": "Pulse Generator, External Pacemaker, Dual Chamber",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Cardiovascular",
      "device_class": "2",
      "definition": "A dual chamber external pacemaker is intended to provide temporary dual chamber cardiac pacing as a substitute for the heart's intrinsic pacing system until a permanent pacemaker can be implanted, or to control irregular heartbeats following cardiac surgery or a myocardial infarction.",
      "regulation_number": "870.3600",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}