{
  "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": "2026-10-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "pma_number": "P140017",
      "supplement_number": "S005",
      "applicant": "Medtronic, Inc.",
      "street_1": "8200 Coral Sea St. NE Mvs83",
      "street_2": "",
      "city": "Mounds View",
      "state": "MN",
      "zip": "55112",
      "zip_ext": "",
      "generic_name": "Pulmonary valve prosthesis percutaneously delivered",
      "trade_name": "MELODY TRANSCATHETER PULMONARY VALVE, ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM and ENSEMBLE II TRANSCATHETER VALVE D",
      "product_code": "NPV",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "Panel Track",
      "supplement_reason": "Labeling Change - Indications/instructions/shelf life/tradename",
      "expedited_review_flag": "Y",
      "date_received": "2016-09-01",
      "decision_date": "2017-02-24",
      "docket_number": "17M-1227",
      "fed_reg_notice_date": "2017-03-10",
      "decision_code": "APPR",
      "ao_statement": "Approval for the Melody Transcatheter Pulmonary Valve, Ensemble Transcatheter Valve Delivery System, and Ensemble II Transcatheter Valve Delivery System for expanding the indications to include patients with a dysfunctional surgical bioprosthetic pulmonary valve. The device is indicated for use in the management of pediatric and adult patients who have a clinical indication for intervention on a dysfunctional right ventricular outflow tract (RVOT) conduit or surgical bioprosthetic pulmonary valve that has >= moderate regurgitation and/or a mean RVOT gradient >= 35 mmHg.",
      "openfda": {
        "registration_number": [
          "9617601",
          "1721676",
          "2024024",
          "2015691",
          "9612164",
          "1318694",
          "3008500478",
          "2011171",
          "3017298588",
          "3007063218",
          "2528981",
          "3044156918",
          "2025587",
          "3002807314"
        ],
        "fei_number": [
          "3002534070",
          "1721676",
          "2024024",
          "2015691",
          "1318694",
          "2011171",
          "3017298588",
          "3002806434",
          "3007063218",
          "2528981",
          "3044156918",
          "1713910",
          "3002807314",
          "2025587"
        ],
        "device_name": "Pulmonary Valve Prosthesis Percutaneously Delivered",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "f"
      }
    }
  ]
}