{
  "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": "2026-08-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "proprietary_name": [
        "Edwards Rail Tray",
        "Edwards Stabilizer Rail System",
        "SAPIEN M3 TRANSCATHETER MITRAL VALVE REPLACEMENT SYSTEM",
        "Edwards Stabilizer Set",
        "Edwards Reusable Accessories - Reusable Platform",
        "PASCAL System - Stabilizer Rail System",
        "Edwards EVOQUE Accessories",
        "Edwards Reusable Accessories - Reusable Plate",
        "Edwards EVOQUE Stabilizer",
        "PASCAL System - Table",
        "Edwards Reusable Accessories - Reusable Cradle",
        "Edwards Reusable Rail",
        "Edwards Reusable Rail Extension"
      ],
      "establishment_type": [
        "Manufacture Medical Device"
      ],
      "registration": {
        "registration_number": "3015179394",
        "fei_number": "3015179394",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "Edwards Lifesciences LTD",
        "address_line_1": "10 Earhart Ave",
        "address_line_2": "Shannon Industrial Estates",
        "city": "Shannon Clare",
        "state_code": "",
        "iso_country_code": "IE",
        "zip_code": "",
        "postal_code": "V14 P638",
        "us_agent": {
          "name": "Denny Kouri",
          "business_name": "EDWARDS LIFESCIENCES LLC",
          "bus_phone_area_code": "949",
          "bus_phone_num": "2502500",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "establishment_registration@edwards.com",
          "address_line_1": "1 Edwards Way",
          "address_line_2": "",
          "city": "Irvine",
          "state_code": "CA",
          "iso_country_code": "US",
          "zip_code": "92614",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "Edwards Lifesciences LLC",
          "owner_operator_number": "9040666",
          "official_correspondent": {
            "first_name": "Denny",
            "middle_initial": "",
            "last_name": "Kouri",
            "subaccount_company_name": "",
            "phone_number": "x-949-2502500-x"
          },
          "contact_address": {
            "address_1": "One Edwards Way",
            "address_2": "",
            "city": "Irvine",
            "state_code": "CA",
            "state_province": "",
            "iso_country_code": "US",
            "postal_code": "92614"
          }
        }
      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "QWA",
          "created_date": "2023-05-17",
          "owner_operator_number": "9040666",
          "exempt": "",
          "openfda": {
            "device_name": "Cardiovascular Delivery Catheter System Positioning And Stabilization Device",
            "medical_specialty_description": "Cardiovascular",
            "regulation_number": "870.3955",
            "device_class": "1"
          }
        }
      ]
    }
  ]
}