{
  "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",
    "results": {
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      "pma_number": "P040036",
      "supplement_number": "S084",
      "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": "NAVISTAR THERMOCOOL, THERMOCOOL SMARTTOUCH",
      "product_code": "LPB",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "Normal 180 Day Track",
      "supplement_reason": "Change Design/Components/Specifications/Material",
      "expedited_review_flag": "N",
      "date_received": "2021-06-30",
      "decision_date": "2022-03-08",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "Approval for the nGEN Generator (compatible with the THERMOCOOL, NAVISTAR and CELSIUS catheters), the addition of a manufacturing site in Israel to manufacture the nGEN Generator and nGEN Pump, and the addition of a manufacturing site in Mexico to manufacture the Interface Cable between the CELSIUS catheters to the nGEN Generator.",
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}