{
  "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": "2026-10-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 14
    }
  },
  "results": [
    {
      "proprietary_name": [
        "Flushing Tool, Merlin@home Transmitter Software, Durata Active Fixation Leads",
        "Neutrino NxT Models - CDHFA600Q, CDHFA800T, CDHFA600T",
        "Lead Cap IS-1/DF-1/SJ4, Merlin Patient Care System Software, Programmer Software, Wireless USB Adapter",
        "Merlin Cable Adapter, Merlin \"M\" Adapter, Merlin Patient System Analyzer, Slit Suture Sleeve,",
        "Current DR, VR ICDs, Promote ICDs, Merlin Antenna",
        "Guidewire, Stylet, Tip Introducer/Torque Tool, Merlin Patient Care System",
        "Merlin Patient Care System Accessories, Slit Suture Sleeve, Stylet Guide, Vein Pick",
        "Merlin@home Transmitter, 3-Lead ECG Cable, Current+ DR VR, ICDs, Promote+ ICDs, Current DR VR ICDs, Promote+ CRT-Ds",
        "Merlin Patient Care System Software Model 3330 Version 18.1.1",
        "CRT Leads, Quickflex Left Heart Leads",
        "Entrant Models - CDHFA300B, CDHFA300D, CDHFA300Q, CDHFA300T",
        "Gallant Models - CDHFA500B, CDHFA500D, CDHFA500Q, CDHFA500T",
        "Neutrino NxT Models - CDHFA600B, CDHFA600D, CDHFA800B, CDHFA800D, CDHFA800Q",
        "Avant Models CDHFA700B, CDHFA700D, CDHFA700Q, CDHFA700T",
        "Quadra Assura CRT-D, Unify Assura CRT-D",
        "Promote Q CRT-Ds, Promote Quadra CRT-Ds, Quartet Lead, Unify Quadra CRT-D, Wireless Broadband Kit",
        "Promote CRT-Ds, Stylet Kit,",
        "QuickFlex Micro Lead, Promote Accel CRT-Ds, Fortify VD DR ICDs, Unify CRT-Ds, Merlin Antenna Adapter",
        "IS4/DF4 Connector Sleeve, IS4/DF4 Plug Accessory Kit, Ellipse DR ICD, Ellipse VR ICD. Fortify Assura ICD"
      ],
      "establishment_type": [
        "Manufacture Medical Device"
      ],
      "registration": {
        "registration_number": "3006705815",
        "fei_number": "3006705815",
        "status_code": "1",
        "initial_importer_flag": "Y",
        "reg_expiry_date_year": "2026",
        "name": "Abbott Medical",
        "address_line_1": "LOT A INTERIOR - No. 2 RD KM 67.5",
        "address_line_2": "SANTANA INDUSTRIAL PARK",
        "city": "Arecibo",
        "state_code": "PR",
        "iso_country_code": "US",
        "zip_code": "00612",
        "postal_code": "",
        "us_agent": {},
        "owner_operator": {
          "firm_name": "ABBOTT LABORATORIES",
          "owner_operator_number": "1415939",
          "official_correspondent": {},
          "contact_address": {
            "address_1": "100 ABBOTT PARK RD.",
            "address_2": "D-03Q3, AP52-1",
            "city": "Abbott Park",
            "state_code": "IL",
            "state_province": "",
            "iso_country_code": "US",
            "postal_code": "60064"
          }
        }
      },
      "pma_number": "P030054",
      "k_number": "",
      "products": [
        {
          "product_code": "LWS",
          "created_date": "2007-11-09",
          "owner_operator_number": "1415939",
          "exempt": "",
          "openfda": {
            "device_name": "Implantable Cardioverter Defibrillator (Non-Crt)",
            "medical_specialty_description": "Unknown",
            "regulation_number": "",
            "device_class": "3"
          }
        },
        {
          "product_code": "NIK",
          "created_date": "2007-11-09",
          "owner_operator_number": "1415939",
          "exempt": "",
          "openfda": {
            "device_name": "Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)",
            "medical_specialty_description": "Unknown",
            "regulation_number": "",
            "device_class": "3"
          }
        },
        {
          "product_code": "OSR",
          "created_date": "2007-11-09",
          "owner_operator_number": "1415939",
          "exempt": "",
          "openfda": {
            "device_name": "Pacemaker/Icd/Crt Non-Implanted Components",
            "medical_specialty_description": "Unknown",
            "regulation_number": "",
            "device_class": "3"
          }
        },
        {
          "product_code": "LWP",
          "created_date": "2007-11-09",
          "owner_operator_number": "1415939",
          "exempt": "",
          "openfda": {
            "device_name": "Implantable Pulse Generator, Pacemaker (Non-Crt)",
            "medical_specialty_description": "Unknown",
            "regulation_number": "",
            "device_class": "3"
          }
        },
        {
          "product_code": "NVZ",
          "created_date": "2007-11-09",
          "owner_operator_number": "1415939",
          "exempt": "",
          "openfda": {
            "device_name": "Pulse Generator, Permanent, Implantable",
            "medical_specialty_description": "Unknown",
            "regulation_number": "",
            "device_class": "3"
          }
        },
        {
          "product_code": "OJX",
          "created_date": "2007-11-09",
          "owner_operator_number": "1415939",
          "exempt": "",
          "openfda": {
            "pma_number": [
              "P030054"
            ],
            "device_name": "Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode",
            "medical_specialty_description": "Unknown",
            "regulation_number": "",
            "device_class": "3"
          }
        },
        {
          "product_code": "NKE",
          "created_date": "2007-11-09",
          "owner_operator_number": "1415939",
          "exempt": "",
          "openfda": {
            "device_name": "Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)",
            "medical_specialty_description": "Unknown",
            "regulation_number": "",
            "device_class": "3"
          }
        }
      ]
    }
  ]
}