{
  "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": "Biosense Webster, Inc.",
      "street_1": "31 Technology Dr.",
      "street_2": "Suite 200",
      "city": "Irvine",
      "state": "CA",
      "zip": "91618",
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      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "Real-Time Process",
      "supplement_reason": "Change Design/Components/Specifications/Material",
      "expedited_review_flag": "N",
      "date_received": "2025-09-30",
      "decision_date": "2025-12-23",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "a software update to the TRUPULSE™ Generator and an update to the user manual of the nGEN™ Pump to facilitate automatic delivery of irrigation at 30 mL/min upon initiation of energy delivery",
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