{
  "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": {
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  "results": [
    {
      "pma_number": "P030035",
      "supplement_number": "",
      "applicant": "ABBOTT MEDICAL",
      "street_1": "15900 Valley View Ct.",
      "street_2": "",
      "city": "Sylmar",
      "state": "CA",
      "zip": "91335",
      "zip_ext": "",
      "generic_name": "Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)",
      "trade_name": "ANTHEM AND FRONTIER II CRT-P'S",
      "product_code": "NKE",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "",
      "supplement_reason": "",
      "expedited_review_flag": "N",
      "date_received": "2003-08-29",
      "decision_date": "2004-05-13",
      "docket_number": "04M-0250",
      "fed_reg_notice_date": "2004-05-26",
      "decision_code": "APPR",
      "ao_statement": "APPROVAL FOR THE ST. JUDE FRONTIER BIVENTRICULAR CARDIAC PACING SYSTEM.  THE FRONTIER BIVENTRICULAR PACING SYSTEM IS INDICATED FOR MAINTAINING SYNCHRONY OF THE LEFT AND RIGHT VENTRICLES IN PATIENTS WHO HAVE UNDERGONE AN AV NODAL ABLATION FOR CHRONIC ATRIAL FIBRILLATION AND HAVE NYHA CLASS II OR III HEART FAILURE.",
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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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}