{
  "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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      "supplement_number": "S046",
      "applicant": "Biosense Webster, Inc.",
      "street_1": "31 Technology Dr., Suite 200",
      "street_2": "",
      "city": "Irvine",
      "state": "CA",
      "zip": "92618",
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      "generic_name": "Cardiac ablation percutaneous catheter",
      "trade_name": "Stockert SMARTABLATE System",
      "product_code": "LPB",
      "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": "2020-10-27",
      "decision_date": "2021-09-23",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "Approval for a new manufacturing site located at STOCKERT GMBH, Boetzinger Strasse 31, Freiburg, Baden-Wurttemberg, Germany D-79111 for the manufacturing of the SMARTABLATE® System (which consists of the SMARTABLATE® Radiofrequency (RF) Generator, SMARTABLATE® Remote Control, SMARTABLATE® Irrigation Pump).",
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}