{
  "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",
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  "results": [
    {
      "pma_number": "P010031",
      "supplement_number": "",
      "applicant": "Medtronic Cardiac Rhythm Disease Management",
      "street_1": "8200 Coral Sea St. N.E",
      "street_2": "",
      "city": "Mounds View",
      "state": "MN",
      "zip": "55112",
      "zip_ext": "",
      "generic_name": "Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)",
      "trade_name": "CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION",
      "product_code": "NIK",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "",
      "supplement_reason": "",
      "expedited_review_flag": "Y",
      "date_received": "2001-05-04",
      "decision_date": "2002-06-26",
      "docket_number": "02M-0381",
      "fed_reg_notice_date": "2002-08-26",
      "decision_code": "APPR",
      "ao_statement": "APPROVAL FOR THE INSYNC ICD MODEL 7272 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WITH CARDIAC RESYNCHRONIZATION THERAPY AND THE MODEL 9969 APPLICATION SOFTWARE.  THE INSYNC ICD MODEL 7272 IS INDICATED FOR VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS.  THE SYSTEM IS ALSO INDICATED FOR THE REDUCTION OF THE SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA FUNCTIONAL CLASS III OR IV) IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL MEDICAL THERAPY (AS DEFINED IN THE CLINICAL TRIALS SECTION), AND HAVE A LEFT VENTRICULAR EJECTION FRACTION LESS THAN OR EQUAL TO 35% AND A QRS DURATION GREATER THAN OR EQUAL TO 130 MS.",
      "openfda": {
        "device_name": "Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "registration_number": [
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