{
  "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": [
    {
      "pma_number": "P050023",
      "supplement_number": "",
      "applicant": "Biotronik, Inc.",
      "street_1": "6024 Jean Rd.",
      "street_2": "",
      "city": "Lake Oswego",
      "state": "OR",
      "zip": "97035",
      "zip_ext": "",
      "generic_name": "DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER",
      "trade_name": "TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD",
      "product_code": "MRM",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "",
      "supplement_reason": "",
      "expedited_review_flag": "N",
      "date_received": "2005-07-11",
      "decision_date": "2006-08-10",
      "docket_number": "06M-0367",
      "fed_reg_notice_date": "2006-09-08",
      "decision_code": "APPR",
      "ao_statement": "APPROVAL FOR THE TUPOS LV/ATX CRT-D, KRONOS LV-T CRT-D, 505.U PROGRAMMER SOFTWARE FOR THE ICS 3000, A-K00.7.U PROGRAMMER SOFTWARE FOR THE EPR/TMS 1000PLUS AND COROX OTW STEROID LEAD.  THE TUPOS LV/ATX AND KRONOS LV-T CRT-DS ARE INDICATED FOR USE IN PATIENTS WITH ALL OF THE FOLLOWING CONDITIONS: 1) INDICATED FOR ICD THERAPY; 2) RECEIVING OPTIMIZED AND STABLE CONGESTIVE HEART FAILURE (CHF) DRUG THERAPY; 3) SYMPTOMATIC CHF (NYHA CLASS III/IV AND LVEF <=35%); AND 4) INTRAVENTRICULAR CONDUCTION DELAY (QRS DURATION >=130 MS).  THE TUPOS LV/ATX IS ALSO INDICATED FOR PATIENTS WHO, IN ADDITION TO AN INDICATION FOR A CRT-D DEVICE, HAVE ATRIAL TACHYARRHYTHMIAS OR ARE AT RISK OF DEVELOPING ATRIAL TACHYARRHYTHMIAS.  THE COROX OTW STEROID LEADS ARE INTENDED FOR IMPLANTATION VIA THE CORONARY VEINS TO PROVIDE LONG TERM CARDIAC PACING WHEN USED IN CONJUNCTION WITH A COMPATIBLE PULSE GENERATOR.",
      "openfda": {
        "registration_number": [
          "9610139",
          "3005941719",
          "3008159616",
          "3002806603",
          "1000165971",
          "1028232"
        ],
        "fei_number": [
          "3008159616",
          "3002806500",
          "3002806603",
          "1000165971",
          "1028232",
          "3002807111"
        ],
        "device_name": "Defibrillator, Implantable, Dual-Chamber",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}