{
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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": "2026-10-05",
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    {
      "pma_number": "P140031",
      "supplement_number": "S085",
      "applicant": "Edwards Lifesciences, LLC",
      "street_1": "One Edwards Way",
      "street_2": "",
      "city": "Irvine",
      "state": "CA",
      "zip": "92614",
      "zip_ext": "",
      "generic_name": "Aortic valve, prosthesis, percutaneously delivered",
      "trade_name": "SAPIEN 3 Ultra transcatheter heart valve",
      "product_code": "NPT",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "Panel Track",
      "supplement_reason": "Labeling Change - Indications/instructions/shelf life/tradename",
      "expedited_review_flag": "N",
      "date_received": "2019-04-01",
      "decision_date": "2019-08-16",
      "docket_number": "19m-3845",
      "fed_reg_notice_date": "2019-08-16",
      "decision_code": "APPR",
      "ao_statement": "Approval for the Edwards SAPIEN 3 Transcatheter Heart Valve System and Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System for expanding the indication to include patients at low risk for surgical aortic valve replacement. The devices are indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy.",
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        "device_name": "Aortic Valve, Prosthesis, Percutaneously Delivered",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
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