{
  "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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      "applicant": "Medtronic Cryocath, LP",
      "street_1": "8200 Coral Sea St., Ms Mv S46",
      "street_2": "",
      "city": "Mounds View",
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      "zip": "55112",
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      "advisory_committee": "CV",
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      "supplement_type": "30-Day Notice",
      "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
      "expedited_review_flag": "N",
      "date_received": "2023-05-02",
      "decision_date": "2023-06-01",
      "docket_number": "",
      "decision_code": "OK30",
      "ao_statement": "New supplier for the Y-Block, Service Loop Top, and Service Loop Bottom components of the Arctic Front Advance and Arctic Front Advance Pro cryoablation catheters. Additionally, there are also minor updates to the molds and dimension of the components due to the new molding processes.",
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