{
  "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": "Medtronic Cryocath, LP",
      "street_1": "8200 Coral Sea St.",
      "street_2": "",
      "city": "Mounds View",
      "state": "MN",
      "zip": "55112",
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      "generic_name": "Cardiac ablation percutaneous catheter",
      "trade_name": "7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM",
      "product_code": "LPB",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "",
      "supplement_reason": "",
      "expedited_review_flag": "N",
      "date_received": "2002-10-23",
      "decision_date": "2003-04-17",
      "docket_number": "05M-0475",
      "fed_reg_notice_date": "2005-11-28",
      "decision_code": "APPR",
      "ao_statement": "APPROVAL FOR THE 7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM.  THE DEVICE IS INDICATED FOR THE CRYOABLATION OF THE CONDUCTING TISSUES OF THE HEART IN THE TREATMENT OF PATIENTS WITH ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT).",
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}