{
  "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/",
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      "applicant": "Medtronic, Inc.",
      "street_1": "8200 Coral Sea St.",
      "street_2": "Ms Mvs11",
      "city": "Mounds View",
      "state": "MN",
      "zip": "55112",
      "zip_ext": "",
      "generic_name": "Implantable cardioverter defibrillator (non-CRT)",
      "trade_name": "MEDTRONIC(R) JEWEL(R) AF 7250 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, MODEL 9961 PROGRAMMER APPLICATION SOF",
      "product_code": "LWS",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "",
      "supplement_reason": "",
      "expedited_review_flag": "N",
      "date_received": "1998-12-24",
      "decision_date": "2000-06-14",
      "docket_number": "00M-1389",
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      "decision_code": "APPR",
      "ao_statement": "APPROVAL FOR THE MEDTRONIC(R) JEWEL(R) AF 7250 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), MODEL 9961 PROGRAMMER APPLICATION SOFTWARE, AND MEDTRONIC(R) SPRINT(TM) MODEL 6943 STEROID ELUTING, SCREW-IN, ATRIAL/VENTRICULAR LEAD.  THIS SYSTEM IS INDICATED FOR USE IN ICD PATIENTS EITHER WITH ATRIAL TACHYARRHYTHMIAS OR WHO ARE AT SIGNIFICANT RISK OF DEVELOPING ATRIAL TACHYARRHYTHMIAS.  PATIENTS INDICATED FOR AN ICD ARE THOSE PATIENTS WHO ARE AT RISK OF SUDDEN DEATH DUE TO VENTRICULAR...",
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