{
  "release_id": "5dcd9b263fe17744",
  "id": "cardio:melody-transcatheter-pulmonary-valve",
  "owner": "cardio",
  "kind": "product",
  "slug": "melody-transcatheter-pulmonary-valve",
  "name": "Melody transcatheter pulmonary valve",
  "aliases": [
    "Melody TPV",
    "Melody valve"
  ],
  "atlases": [
    "cardio"
  ],
  "summary_plain": "A replacement valve from Medtronic, put in through a catheter, for a failing right ventricular outflow tract (RVOT) conduit (a full conduit of 16 mm or more when implanted, with at least moderate regurgitation and/or a mean gradient of 35 mmHg or more) or, since 2017, a surgical pulmonary valve. A US government patient page places the pulmonary valve between the right lower heart chamber and the lung artery. FDA first authorized it in 2010 under a humanitarian device exemption, approved the full premarket application in 2015 as a conversion of that exemption, for children and adults with a dysfunctional right ventricular outflow tract conduit, and in 2017 widened the approval to a dysfunctional surgical bioprosthetic pulmonary valve. The approval records read here report no trial results.",
  "summary_technical": "Melody Transcatheter Pulmonary Valve (TPV) with the Ensemble Transcatheter Valve Delivery System, FDA product code NPV, PMA P140017, approved 2015-01-27 for children and adults whose right ventricular outflow tract (RVOT) conduit has stopped working properly and measured 16 mm or more across when implanted. Supplement S005, 2017-02-24, adds a malfunctioning surgical bioprosthetic pulmonary valve with at least moderate regurgitation or a mean RVOT gradient of at least 35 mmHg and names the Ensemble II delivery system. The openFDA order text for the original approval ends the gradient threshold without its number; the summary of safety and effectiveness gives 35 mmHg. That summary also says the 2015 PMA is a conversion from the original humanitarian device exemption H080002, approved on January 25, 2010. openFDA gives the device class as f for this record. No trial results are recorded here.",
  "editorial_state": "draft",
  "last_substantive_edit": "2026-10-15",
  "last_evidence_check": "2026-10-14",
  "next_review_due": null,
  "identifiers": [],
  "navigation": {
    "cardio": {
      "system": [
        "heart"
      ],
      "condition-area": [
        "valvular-and-congenital-disease"
      ]
    }
  },
  "payload": {
    "subtype": "device",
    "model_or_formulation": "Melody Transcatheter Pulmonary Valve (TPV) with the Ensemble and Ensemble II delivery systems",
    "version": "The original approval names the Melody TPV and the Ensemble delivery system. The 2017 supplement adds the Ensemble II delivery system. Later supplements are not read here.",
    "intended_use_snapshots": [
      "cardio:openfda-pma-p140017-2026-10-14",
      "cardio:openfda-pma-p140017-s005-2026-10-14"
    ]
  },
  "content_digest": "e713ba1bf995b2d77b9daaa4a169e3823c6c54ef900e9191c6165fd30b2898d5",
  "review": {
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    "current": [],
    "conflicting": [],
    "stale": [],
    "inactive": []
  },
  "claims": [
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      "owner": "cardio",
      "subject_entity_id": "cardio:melody-transcatheter-pulmonary-valve",
      "category": "regulatory",
      "statement": "On 2015-01-27 the US Food and Drug Administration approved the Melody Transcatheter Pulmonary Valve (TPV), together with its Ensemble delivery system, under PMA P140017, product code NPV, applicant Medtronic, Inc. According to the approval order, the valve is meant as an addition to surgical care of children and adults whose right ventricular outflow tract (RVOT) conduit is a complete (circumferential) tube that measured 16 mm or more across when first implanted and that has since stopped working properly. The person must also have a clinical reason for intervention and at least moderate regurgitation, stenosis with a mean RVOT gradient of 35 mmHg or more, or both. The openFDA order text ends that threshold without its number; the 35 mmHg comes from the summary of safety and effectiveness.",
      "context": {
        "id": "cardio:ctx-fda-p140017-rvot-conduit",
        "label": "United States PMA approval P140017: Melody valve for a dysfunctional right ventricular outflow tract conduit",
        "recipient": "mixed",
        "population": "Children and adults whose right ventricular outflow tract (RVOT) conduit is a complete (circumferential) tube that measured 16 mm or more across when implanted and that is now malfunctioning, with a clinical reason for intervention and at least moderate regurgitation, stenosis with a mean RVOT gradient of 35 mmHg or more, or both.",
        "care_setting": "Used as an addition to surgical care for these patients (order wording, paraphrased)",
        "geography": "United States (decision by the US Food and Drug Administration)",
        "life_stage_note": "Pediatric and adult patients, as the order words it; no age bounds are given",
        "life_stage_terms": null,
        "gestational_age_min_days": null,
        "gestational_age_max_days": null,
        "gestational_age_basis": null,
        "postnatal_age_min_days": null,
        "postnatal_age_max_days": null,
        "gestational_age_status": null,
        "postnatal_age_status": null,
        "followup_description": "Not applicable (regulatory decision)",
        "eligibility": {
          "inclusion": [
            "A complete (circumferential) RVOT conduit that measured at least 16 mm across when first implanted",
            "An RVOT conduit that is no longer working properly, with a clinical reason for intervention",
            "At least moderate regurgitation, stenosis with a mean RVOT gradient of 35 mmHg or more, or both"
          ],
          "exclusion": []
        }
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      "evidence_stage": "not_applicable",
      "certainty": "not_assessed",
      "certainty_method": null,
      "limitations": "openFDA copies the approval order statement and may lose characters; where a symbol is missing it is not restored here. The FDA PMA database page, the approval order and the summary of safety and effectiveness were not read, so conditions of approval and trial results are not recorded. An approval is a regulatory decision and not a finding about how well the device works for any person. openFDA's own disclaimer says not to rely on it to make decisions regarding medical care. openFDA gives the device class of this record as f, which this record does not translate into a class.",
      "editorial_state": "draft",
      "checked_at": "2026-10-14",
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      "statement": "On 2017-02-24 the US Food and Drug Administration approved PMA supplement S005 to P140017, applicant Medtronic, Inc., for the Melody Transcatheter Pulmonary Valve with the Ensemble and Ensemble II delivery systems. The supplement adds people whose surgically placed bioprosthetic pulmonary valve has stopped working properly to the approved uses. The approved use covers children and adults with a clinical reason for intervention on a malfunctioning RVOT conduit, or on a bioprosthetic pulmonary valve placed by surgery, that shows at least moderate regurgitation, a mean RVOT gradient of 35 mmHg or more, or both.",
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        "label": "United States PMA supplement P140017 S005: Melody valve for a dysfunctional surgical bioprosthetic pulmonary valve",
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        "care_setting": "Not stated in the FDA record",
        "geography": "United States (decision by the US Food and Drug Administration)",
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      "limitations": "openFDA copies the approval order statement and may lose characters; where a symbol is missing it is not restored here. The FDA PMA database page, the approval order and the summary of safety and effectiveness were not read, so conditions of approval and trial results are not recorded. An approval is a regulatory decision and not a finding about how well the device works for any person. openFDA's own disclaimer says not to rely on it to make decisions regarding medical care.",
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            "edition": "The openFDA PMA record returned on 2026-10-14 for P140017 supplement S005, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.",
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          "locator": "page 1, Re: line",
          "applicability_note": "The FDA approval order names the supplement as P140017/S005.",
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            "id": "cardio:fda-p140017-s005-order",
            "source_type": "regulator",
            "title": "FDA approval order for PMA supplement P140017/S005 (Melody valve, surgical bioprosthetic pulmonary valve)",
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              }
            ],
            "publication_date": null,
            "publisher": "U.S. Food and Drug Administration",
            "edition": "PDF fetched 2026-10-14; text read with pdftotext. The decision document of the FDA PMA database.",
            "reuse_basis": "FDA document fetched 2026-10-14 from accessdata.fda.gov. FDA's own website reuse terms were not read for this atlas, so public text is cite_only until they are. Hash only; the PDF is not committed.",
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    },
    {
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      "id": "cardio:claim-melody-approved-scope",
      "owner": "cardio",
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      "category": "descriptive",
      "statement": "The Melody Transcatheter Pulmonary Valve is FDA-approved, as an adjunct to surgery, for pediatric and adult patients with a full (circumferential) right ventricular outflow tract conduit that was 16 mm or more when implanted and is now dysfunctional, with a clinical indication for intervention and at least moderate regurgitation and/or stenosis with a mean gradient of 35 mmHg or more. These statements say what the device is approved for in its original approval. They are not findings about how well it works or how safe it is. The 2017 supplement that added a dysfunctional surgical bioprosthetic pulmonary valve has its own decision record.",
      "context": {
        "id": "cardio:ctx-fda-p140017-rvot-conduit",
        "label": "United States PMA approval P140017: Melody valve for a dysfunctional right ventricular outflow tract conduit",
        "recipient": "mixed",
        "population": "Children and adults whose right ventricular outflow tract (RVOT) conduit is a complete (circumferential) tube that measured 16 mm or more across when implanted and that is now malfunctioning, with a clinical reason for intervention and at least moderate regurgitation, stenosis with a mean RVOT gradient of 35 mmHg or more, or both.",
        "care_setting": "Used as an addition to surgical care for these patients (order wording, paraphrased)",
        "geography": "United States (decision by the US Food and Drug Administration)",
        "life_stage_note": "Pediatric and adult patients, as the order words it; no age bounds are given",
        "life_stage_terms": null,
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        "gestational_age_basis": null,
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        "gestational_age_status": null,
        "postnatal_age_status": null,
        "followup_description": "Not applicable (regulatory decision)",
        "eligibility": {
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            "A complete (circumferential) RVOT conduit that measured at least 16 mm across when first implanted",
            "An RVOT conduit that is no longer working properly, with a clinical reason for intervention",
            "At least moderate regurgitation, stenosis with a mean RVOT gradient of 35 mmHg or more, or both"
          ],
          "exclusion": []
        }
      },
      "evidence_stage": "not_applicable",
      "certainty": "not_assessed",
      "certainty_method": null,
      "limitations": "Describes the approval scope only. The orders cited report no trial results and no comparison with surgery; the summaries of safety and effectiveness were not read. The patients are described as pediatric and adult, so this atlas files the record under adult congenital heart disease for navigation only. The 2017 supplement has its own context, claim and decision record.",
      "editorial_state": "draft",
      "checked_at": "2026-10-14",
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      "citations": [
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          "source": {
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            "source_type": "regulator",
            "title": "FDA premarket approval record P140017: Melody Transcatheter Pulmonary Valve and Ensemble delivery system (original PMA approval) (openFDA record)",
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            "publisher": "U.S. Food and Drug Administration (openFDA)",
            "edition": "The openFDA PMA record returned on 2026-10-14 for P140017 (the earliest record by decision date, which is the original approval, with no supplement number), from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.",
            "reuse_basis": "openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P140017.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.",
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          "applicability_note": "The summary of safety and effectiveness prints the regurgitation and mean gradient criteria, including 35 mmHg.",
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            "source_type": "regulator",
            "title": "FDA summary of safety and effectiveness data for PMA P140017 (Melody valve)",
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            "edition": "PDF fetched 2026-10-14; text read with pdftotext. The decision document of the FDA PMA database.",
            "reuse_basis": "FDA document fetched 2026-10-14 from accessdata.fda.gov. FDA's own website reuse terms were not read for this atlas, so public text is cite_only until they are. Hash only; the PDF is not committed.",
            "public_text": "cite_only"
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  "decisions": [
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      "id": "cardio:regdec-fda-p140017-s005",
      "product_id": "cardio:melody-transcatheter-pulmonary-valve",
      "product_version": "Melody Transcatheter Pulmonary Valve with the Ensemble and Ensemble II delivery systems (PMA supplement S005)",
      "indication": "PMA supplement S005 expands the indications to include pediatric and adult patients with a dysfunctional RVOT conduit or surgical bioprosthetic pulmonary valve, with at least moderate regurgitation and/or a mean RVOT gradient of 35 mmHg or more.",
      "context_id": "cardio:ctx-fda-p140017-s005-bioprosthetic-pulmonary-valve",
      "jurisdictions": [
        "US"
      ],
      "jurisdiction_note": "United States",
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      "pathway": "pma",
      "product_code": "NPV",
      "device_class": null,
      "decision_date": "2017-02-24",
      "valid_to": null,
      "claim_id": "cardio:claim-fda-p140017-s005-bioprosthetic-valve"
    },
    {
      "type": "regulatory_decision",
      "id": "cardio:regdec-fda-p140017",
      "product_id": "cardio:melody-transcatheter-pulmonary-valve",
      "product_version": "Melody Transcatheter Pulmonary Valve (TPV) and Ensemble Transcatheter Valve Delivery System (original approval)",
      "indication": "Adjunct to surgery in the management of pediatric and adult patients with a full RVOT conduit that was 16 mm or more when implanted and that is now dysfunctional with a clinical indication for intervention (at least moderate regurgitation, and/or stenosis with a mean RVOT gradient of 35 mmHg or more).",
      "context_id": "cardio:ctx-fda-p140017-rvot-conduit",
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      "product_code": "NPV",
      "device_class": null,
      "decision_date": "2015-01-27",
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}