{
  "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": "Boston Scientific",
      "street_1": "4100 Hamline Ave. N",
      "street_2": "",
      "city": "St Paul",
      "state": "MN",
      "zip": "55112",
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      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "Normal 180 Day Track No User Fee",
      "supplement_reason": "Location Change - Manufacturer/Sterilizer/Packager/Supplier",
      "expedited_review_flag": "N",
      "date_received": "2023-06-21",
      "decision_date": "2024-04-05",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "manufacturing site transfer for the Rx Sterile Catheter Cables and Non-Sterile Recording System Electrogram (EGM) Cable to Amphenol Alden Products Company in Hermosillo, Mexico; Amphenol Alden Products Company in Shenzhen, China; and Carrio Cabling Corporation in Colorado Springs, Colorado",
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