{
  "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": "P060019",
      "supplement_number": "",
      "applicant": "Irvine Biomedical, Inc.",
      "street_1": "2375 Morse Ave.",
      "street_2": "",
      "city": "Irvine",
      "state": "CA",
      "zip": "92614",
      "zip_ext": "",
      "generic_name": "catheter, percutaneous, cardiac ablation, for treatment of atrial flutter",
      "trade_name": "IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF",
      "product_code": "OAD",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "",
      "supplement_reason": "",
      "expedited_review_flag": "N",
      "date_received": "2006-05-30",
      "decision_date": "2007-03-16",
      "docket_number": "07M-0108",
      "fed_reg_notice_date": "2007-03-26",
      "decision_code": "APPR",
      "ao_statement": "APPROVAL FOR THE THERAPY COOL PATH ABLATION CATHETER AND IBI 1500T9 RF ABLATION GENERATOR.  THE THERAPY COOL PATH ABLATION CATHETER IS INTENDED FOR USE WITH A COMPATIBLE EXTERNAL INFUSION PUMP AND THE IBI 1500T9 RADIOFREQUENCY (RF) GENERATOR AT A MAXIMUM OF 50 WATTS.  THE CATHETER IS INTENDED FOR CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES (MAPPING, STIMULATION AND ABLATION) FOR THE TREATMENT OF TYPICAL ATRIAL FLUTTER.  THE IBI 1500T9 RF ABLATION GENERATOR IS INTENDED FOR USE WITH COMPATIBLE ST. JUDE MEDICAL TEMPERATURE CONTROLLED ABLATION CATHETERS FOR CREATING ENDOCARDIAL LESIONS TO TREAT CARDIAC ARRHYTHMIAS (I.E. SUPRAVENTRICULAR TACHYCARDIAS, AND ATRIAL FLUTTER).  THE GENERATOR IS INTERNALLY LIMITED TO 50 WATTS WHEN USED WITH THE THERAPY COOL PATH CATHETERS.  A COMPATIBLE EXTERNAL INFUSION PUMP MUST BE CONNECTED WHEN USED WITH THERAPY COOL PATH CATHETERS.",
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        "device_name": "Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
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}