{
  "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": 28
    }
  },
  "results": [
    {
      "proprietary_name": [
        "Evia HF(-T)",
        "Entovis HF(-T)",
        "Renamic",
        "CardioMessenger",
        "PSW 1301.U",
        "Sentus OTW QP L/S",
        "Enitra",
        "Edora",
        "Enticos",
        "Evity",
        "Stratos",
        "Corox",
        "Celerity",
        "LV-KIT",
        "ICS 3000",
        "Home Monitoring"
      ],
      "establishment_type": [
        "Repack or Relabel Medical Device"
      ],
      "registration": {
        "registration_number": "1028232",
        "fei_number": "1028232",
        "status_code": "1",
        "initial_importer_flag": "Y",
        "reg_expiry_date_year": "2026",
        "name": "BIOTRONIK, INC.",
        "address_line_1": "6024 JEAN RD.",
        "address_line_2": "",
        "city": "LAKE OSWEGO",
        "state_code": "OR",
        "iso_country_code": "US",
        "zip_code": "97035",
        "postal_code": "",
        "us_agent": {},
        "owner_operator": {
          "firm_name": "BIOTRONIK, INC.",
          "owner_operator_number": "1028232",
          "official_correspondent": {
            "first_name": "JON",
            "middle_initial": "-",
            "last_name": "BRUMBAUGH",
            "subaccount_company_name": "",
            "phone_number": "x-503-4518310-x"
          },
          "contact_address": {
            "address_1": "6024 JEAN RD.",
            "address_2": "--",
            "city": "Lake Oswego",
            "state_code": "OR",
            "state_province": "",
            "iso_country_code": "US",
            "postal_code": "97035"
          }
        }
      },
      "pma_number": "P070008",
      "k_number": "",
      "products": [
        {
          "product_code": "NKE",
          "created_date": "2008-05-21",
          "owner_operator_number": "1028232",
          "exempt": "",
          "openfda": {
            "device_name": "Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)",
            "medical_specialty_description": "Unknown",
            "regulation_number": "",
            "device_class": "3"
          }
        },
        {
          "product_code": "NIK",
          "created_date": "2008-05-21",
          "owner_operator_number": "1028232",
          "exempt": "",
          "openfda": {
            "device_name": "Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)",
            "medical_specialty_description": "Unknown",
            "regulation_number": "",
            "device_class": "3"
          }
        },
        {
          "product_code": "OJX",
          "created_date": "2008-05-21",
          "owner_operator_number": "1028232",
          "exempt": "",
          "openfda": {
            "device_name": "Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode",
            "medical_specialty_description": "Unknown",
            "regulation_number": "",
            "device_class": "3"
          }
        },
        {
          "product_code": "NVZ",
          "created_date": "2008-05-21",
          "owner_operator_number": "1028232",
          "exempt": "",
          "openfda": {
            "device_name": "Pulse Generator, Permanent, Implantable",
            "medical_specialty_description": "Unknown",
            "regulation_number": "",
            "device_class": "3"
          }
        },
        {
          "product_code": "LWS",
          "created_date": "2008-05-21",
          "owner_operator_number": "1028232",
          "exempt": "",
          "openfda": {
            "device_name": "Implantable Cardioverter Defibrillator (Non-Crt)",
            "medical_specialty_description": "Unknown",
            "regulation_number": "",
            "device_class": "3"
          }
        }
      ]
    }
  ]
}