{
  "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",
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      "supplement_number": "",
      "applicant": "ABBOTT MEDICAL",
      "street_1": "2375 Morse Ave.",
      "street_2": "",
      "city": "Plymouth",
      "state": "MN",
      "zip": "55442",
      "zip_ext": "",
      "generic_name": "catheter, percutaneous, cardiac ablation, for treatment of atrial flutter",
      "trade_name": "THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR",
      "product_code": "OAD",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "",
      "supplement_reason": "",
      "expedited_review_flag": "N",
      "date_received": "2011-04-15",
      "decision_date": "2012-01-25",
      "docket_number": "12M-0112",
      "fed_reg_notice_date": "2012-02-02",
      "decision_code": "APPR",
      "ao_statement": "APPROVAL FOR THE THERAPY COOL PATH DUO ABLATION CATHETER; SAFIRE BLU DUO ABLATION CATHETER; AND IBI 1500T-9 VI.6 CARDIAC ABLATION GENERATOR. THIS DEVICE IS INDICATED FOR USE WITH THE COMPATIBLE IRRIGATION PUMPAND 1500T9-CP 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.",
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        "medical_specialty_description": "Unknown",
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        "device_class": "3"
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