{
  "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": {
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  "results": [
    {
      "pma_number": "P030005",
      "supplement_number": "",
      "applicant": "Guidant Corp.",
      "street_1": "4100 Hamline Ave. N",
      "street_2": "",
      "city": "St Paul",
      "state": "MN",
      "zip": "55112",
      "zip_ext": "",
      "generic_name": "Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)",
      "trade_name": "CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE",
      "product_code": "NKE",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "",
      "supplement_reason": "",
      "expedited_review_flag": "N",
      "date_received": "2003-03-24",
      "decision_date": "2004-01-26",
      "docket_number": "04M-0064",
      "fed_reg_notice_date": "2004-02-24",
      "decision_code": "APPR",
      "ao_statement": "APPROVAL FOR THE CONTAK RENEWAL TR.  THE DEVICE IS INDICATED S FOLLOWS:  THE CONTAK RENEWAL TR PULSE GENERATOR IS INDICATED FOR PATIENTS WHO HAVE MODERATE TO SEVERE HEART FAILURE (NYHA CLASS III/IV) INCLUDING LEFT VENTRICULAR DYSFUNCTION (EF <= 35%) AND QRS DURATION >= 120 MS AND REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL HEART FAILURE DRUG THERAPY (AS DEFINED IN THE CLINICAL TRIALS SECTION).  THE DEVICE PROVIDES ATRIAL-VENTRICULAR TRACKING MODES TO HELP PRESERVE AV SYNCHRONY, AND ADAPTIVE-RATE PACING FOR PATIENTS WHO WOULD BENEFIT FROM ADJUSTED PACING RATES CONCURRENT WITH PHYSICAL ACTIVITY.",
      "openfda": {
        "registration_number": [
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        ],
        "device_name": "Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
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}