{
  "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, Inc.",
      "street_1": "8200 Coral Sea St. N.E",
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      "city": "Mounds View",
      "state": "MN",
      "zip": "55112",
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      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "30-Day Notice",
      "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
      "expedited_review_flag": "N",
      "date_received": "2024-08-27",
      "decision_date": "2024-09-06",
      "docket_number": "",
      "decision_code": "OK30",
      "ao_statement": "duplication of a subassembly line at an alternate manufacturing facility for the PulseSelect catheter shaft and array subassembly, including minor manufacturing changes",
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