{
  "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": "2026-06-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 185
    }
  },
  "results": [
    {
      "pma_number": "P110021",
      "supplement_number": "S005",
      "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": "EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES",
      "product_code": "NPT",
      "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": "2012-12-14",
      "decision_date": "2013-06-11",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "APPROVAL FOR THE USE OF THE RE-DESIGNED AND RE-PROGRAMMED SENSITECH TAGALERT TEMPERATURE ALARM INDICATION WITH NEW ELECTROMAGNETIC INFERENCE/ELECTROMAGNETIC DISCHARGE (EMI/ESE) PROTECTION IN THE DEVICES.",
      "openfda": {
        "registration_number": [
          "3017298588",
          "3015287573",
          "3007113487",
          "3005941719",
          "3009420598",
          "3012179728",
          "3014918977",
          "2182269",
          "3002807314",
          "3012148004",
          "3007063218",
          "1721676",
          "3010421104",
          "3010432890",
          "2135147",
          "9617601",
          "3011894841",
          "9612164",
          "3008500478",
          "2025587",
          "2011171",
          "3009380063",
          "2015691"
        ],
        "fei_number": [
          "3017298588",
          "3015287573",
          "3007113487",
          "3009420598",
          "3012179728",
          "3014918977",
          "2182269",
          "3002807314",
          "3012148004",
          "3007063218",
          "1721676",
          "3010421104",
          "3002806434",
          "3002807111",
          "3010432890",
          "3002534070",
          "3011894841",
          "1713910",
          "3005334138",
          "2025587",
          "2011171",
          "3009380063",
          "2015691"
        ],
        "device_name": "Aortic Valve, Prosthesis, Percutaneously Delivered",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}