{
  "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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      "applicant": "Irvine Biomedical, Inc.",
      "street_1": "2375 Morse Ave.",
      "street_2": "",
      "city": "Irvine",
      "state": "CA",
      "zip": "92614",
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      "generic_name": "Cardiac ablation percutaneous catheter",
      "trade_name": "IBI THERAPY CARDIAC ABLATION SYSTEM                    ERS/ 1500T RF GENERATOR",
      "product_code": "LPB",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
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      "supplement_reason": "",
      "expedited_review_flag": "N",
      "date_received": "2004-03-15",
      "decision_date": "2005-01-14",
      "docket_number": "05M-0088",
      "fed_reg_notice_date": "2005-03-09",
      "decision_code": "APPR",
      "ao_statement": "APPROVAL FOR THE IBI THERAPY CARDIAC ABLATION SYSTEM.  THE DEVICE IS INDICATED FOR MAPPING AND FOR USE WITH A COMPATIBLE RF GENERATOR FOR: INTERRUPTION OF ACCESSORY ATRIOVENTRICULAR (AV) CONDUCTION PATHWAYS ASSOCIATED WITH TACHYCARDIA; THE TREATMENT OF AV NODAL RE-ENTRANT TACHYCARDIA (AVNRT); OR CREATION OF COMPLETE AV NODAL BLOCK IN PATIENTS WITH A DIFFICULT TO CONTROL VENTRICULAR RESPONSE TO AN ATRIAL ARRHYTHMIA.",
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}