{
  "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_description": "Cardiovascular",
      "supplement_type": "30-Day Notice",
      "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
      "expedited_review_flag": "N",
      "date_received": "2024-12-03",
      "decision_date": "2024-12-23",
      "docket_number": "",
      "decision_code": "OK30",
      "ao_statement": "a change in Bacterial Endotoxin Testing (BET) for the Sphere-9 Catheter and Tubing Set, Ethylene Oxide (EO) sterilized atProfessional Contract Sterilization (PCS) in Taunton, Massachusetts and Sterigenics in Queensbury, New York",
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