{
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    "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": "2026-08-03",
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      "pma_number": "P850064",
      "supplement_number": "S015",
      "applicant": "Bunnell, Inc.",
      "street_1": "436 Lawndale Dr.",
      "street_2": "",
      "city": "Salt Lake City",
      "state": "UT",
      "zip": "84115",
      "zip_ext": "",
      "generic_name": "VENTILATOR, HIGH FREQUENCY",
      "trade_name": "LIFE PULSE HIGH FREQUENCY VENTILATOR",
      "product_code": "LSZ",
      "advisory_committee": "AN",
      "advisory_committee_description": "Anesthesiology",
      "supplement_type": "Normal 180 Day Track",
      "supplement_reason": "Labeling Change - Indications/instructions/shelf life/tradename",
      "expedited_review_flag": "N",
      "date_received": "1998-10-21",
      "decision_date": "1999-04-05",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "Approval for extending the duration of use for the breathing circuit.",
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        "device_name": "Ventilator, High Frequency",
        "medical_specialty_description": "Unknown",
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