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Melody transcatheter pulmonary valve

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.

Also called Melody TPV · Melody valve

  • Product
  • In this atlas

Overview

Technical summary

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.

Product details

Type
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 sources

  1. Background FDA premarket approval record P140017: Melody Transcatheter Pulmonary Valve and Ensemble delivery system (original PMA approval) (openFDA record)

    Regulator · 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. · PMA: P140017

    Locator
    Whole source
    How it applies
    Source of the stated intended use
    Retrieved
    Source effective date
    2026-10-05
    Source state
    Current
    Snapshot hash
    56ea2833b16f4a7a4c5db1259df3bd54c1965e7e1d21a50b52b3584fc3311a9b
    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.

  2. Background FDA premarket approval record P140017/S005: Melody Transcatheter Pulmonary Valve (PMA supplement S005, surgical bioprosthetic pulmonary valve) (openFDA record)

    Regulator · U.S. Food and Drug Administration (openFDA) · 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.

    Locator
    Whole source
    How it applies
    Source of the stated intended use
    Retrieved
    Source effective date
    2026-10-05
    Source state
    Current
    Snapshot hash
    26d4caf63fadb152906292f1d150372f894261149087da3580cac9fffdabba4d
    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-S005.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.

Claims and evidence

Context United States PMA approval P140017: Melody valve for a dysfunctional right ventricular outflow tract conduit

Recipient
Mixed recipients
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
Pediatric and adult patients, as the order words it; no age bounds are given
Gestational age
Not reported
Postnatal age
Not reported
Follow-up
Not applicable (regulatory decision)
Eligibility: 3 inclusion criteria; exclusion criteria not stated
Included
  • 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
Excluded
None stated

  • Regulatory Evidence stage not applicable Certainty not assessed

    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.

    Applies to Mixed recipients
    • 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.
    • Used as an addition to surgical care for these patients (order wording, paraphrased)
    • United States (decision by the US Food and Drug Administration)
    • Pediatric and adult patients, as the order words it; no age bounds are given
    • Gestational age Not reported
    • Postnatal age Not reported
    Follow-up Not applicable (regulatory decision)
    Certainty method
    Not assessed
    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.
    Last checked
    2026-10-14
    Next evidence check due
    Not scheduled
    Sources and citations (9)

    1. Supports FDA premarket approval record P140017: Melody Transcatheter Pulmonary Valve and Ensemble delivery system (original PMA approval) (openFDA record)

      Regulator · 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. · PMA: P140017

      Locator
      results[0].pma_number
      How it applies
      The PMA number of this record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      56ea2833b16f4a7a4c5db1259df3bd54c1965e7e1d21a50b52b3584fc3311a9b
      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.

    2. Supports FDA premarket approval record P140017: Melody Transcatheter Pulmonary Valve and Ensemble delivery system (original PMA approval) (openFDA record)

      Regulator · 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. · PMA: P140017

      Locator
      results[0].applicant
      How it applies
      The applicant, as FDA writes the name.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      56ea2833b16f4a7a4c5db1259df3bd54c1965e7e1d21a50b52b3584fc3311a9b
      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.

    3. Supports FDA premarket approval record P140017: Melody Transcatheter Pulmonary Valve and Ensemble delivery system (original PMA approval) (openFDA record)

      Regulator · 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. · PMA: P140017

      Locator
      results[0].trade_name
      How it applies
      The trade name FDA gives this record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      56ea2833b16f4a7a4c5db1259df3bd54c1965e7e1d21a50b52b3584fc3311a9b
      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.

    4. Supports FDA premarket approval record P140017: Melody Transcatheter Pulmonary Valve and Ensemble delivery system (original PMA approval) (openFDA record)

      Regulator · 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. · PMA: P140017

      Locator
      results[0].decision_date
      How it applies
      ISO date of the decision.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      56ea2833b16f4a7a4c5db1259df3bd54c1965e7e1d21a50b52b3584fc3311a9b
      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.

    5. Supports FDA premarket approval record P140017: Melody Transcatheter Pulmonary Valve and Ensemble delivery system (original PMA approval) (openFDA record)

      Regulator · 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. · PMA: P140017

      Locator
      results[0].decision_code
      How it applies
      FDA decision code: APPR is an approval.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      56ea2833b16f4a7a4c5db1259df3bd54c1965e7e1d21a50b52b3584fc3311a9b
      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.

    6. Supports FDA premarket approval record P140017: Melody Transcatheter Pulmonary Valve and Ensemble delivery system (original PMA approval) (openFDA record)

      Regulator · 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. · PMA: P140017

      Locator
      results[0].product_code
      How it applies
      FDA product code of this record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      56ea2833b16f4a7a4c5db1259df3bd54c1965e7e1d21a50b52b3584fc3311a9b
      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.

    7. Supports FDA premarket approval record P140017: Melody Transcatheter Pulmonary Valve and Ensemble delivery system (original PMA approval) (openFDA record)

      Regulator · 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. · PMA: P140017

      Locator
      results[0].ao_statement
      How it applies
      FDA approval order statement: the approved indication, quoted in fragments.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      56ea2833b16f4a7a4c5db1259df3bd54c1965e7e1d21a50b52b3584fc3311a9b
      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.

    8. Background FDA premarket approval record P140017: Melody Transcatheter Pulmonary Valve and Ensemble delivery system (original PMA approval) (openFDA record)

      Regulator · 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. · PMA: P140017

      Locator
      meta.disclaimer
      How it applies
      openFDA's own disclaimer about relying on its data.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      56ea2833b16f4a7a4c5db1259df3bd54c1965e7e1d21a50b52b3584fc3311a9b
      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.

    9. Supports FDA summary of safety and effectiveness data for PMA P140017 (Melody valve)

      Regulator · U.S. Food and Drug Administration · Edition PDF fetched 2026-10-14; text read with pdftotext. The decision document of the FDA PMA database.

      Locator
      Section II, Indications for use
      How it applies
      The summary of safety and effectiveness prints the regurgitation and mean gradient criteria, including 35 mmHg.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      81d4e9efac04389bb41e8f2691a6318afebe8381e3f64f06e879c9de8dd62cd2
      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.

  • Description Evidence stage not applicable Certainty not assessed

    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.

    Applies to Mixed recipients
    • 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.
    • Used as an addition to surgical care for these patients (order wording, paraphrased)
    • United States (decision by the US Food and Drug Administration)
    • Pediatric and adult patients, as the order words it; no age bounds are given
    • Gestational age Not reported
    • Postnatal age Not reported
    Follow-up Not applicable (regulatory decision)
    Certainty method
    Not assessed
    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.
    Last checked
    2026-10-14
    Next evidence check due
    Not scheduled
    Sources and citations (2)

    1. Supports FDA premarket approval record P140017: Melody Transcatheter Pulmonary Valve and Ensemble delivery system (original PMA approval) (openFDA record)

      Regulator · 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. · PMA: P140017

      Locator
      results[0].ao_statement
      How it applies
      The original approval order statement: the approved indication.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      56ea2833b16f4a7a4c5db1259df3bd54c1965e7e1d21a50b52b3584fc3311a9b
      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.

    2. Supports FDA summary of safety and effectiveness data for PMA P140017 (Melody valve)

      Regulator · U.S. Food and Drug Administration · Edition PDF fetched 2026-10-14; text read with pdftotext. The decision document of the FDA PMA database.

      Locator
      Section II, Indications for use
      How it applies
      The summary of safety and effectiveness prints the regurgitation and mean gradient criteria, including 35 mmHg.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      81d4e9efac04389bb41e8f2691a6318afebe8381e3f64f06e879c9de8dd62cd2
      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.

Context United States PMA supplement P140017 S005: Melody valve for a dysfunctional surgical bioprosthetic pulmonary valve

Recipient
Mixed recipients
Population
Children and adults with a clinical reason for intervention on a malfunctioning right ventricular outflow tract (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.
Care setting
Not stated in the FDA record
Geography
United States (decision by the US Food and Drug Administration)
Life stage
Pediatric and adult patients, as the order words it; no age bounds are given
Gestational age
Not reported
Postnatal age
Not reported
Follow-up
Not applicable (regulatory decision)
Eligibility: 2 inclusion criteria; exclusion criteria not stated
Included
  • A clinical reason for intervention on a malfunctioning RVOT conduit, or on a bioprosthetic pulmonary valve placed by surgery
  • At least moderate regurgitation, a mean RVOT gradient of 35 mmHg or more, or both
Excluded
None stated

  • Regulatory Evidence stage not applicable Certainty not assessed

    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.

    Applies to Mixed recipients
    • Children and adults with a clinical reason for intervention on a malfunctioning right ventricular outflow tract (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.
    • Not stated in the FDA record
    • United States (decision by the US Food and Drug Administration)
    • Pediatric and adult patients, as the order words it; no age bounds are given
    • Gestational age Not reported
    • Postnatal age Not reported
    Follow-up Not applicable (regulatory decision)
    Certainty method
    Not assessed
    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.
    Last checked
    2026-10-14
    Next evidence check due
    Not scheduled
    Sources and citations (10)

    1. Supports FDA premarket approval record P140017/S005: Melody Transcatheter Pulmonary Valve (PMA supplement S005, surgical bioprosthetic pulmonary valve) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · 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.

      Locator
      results[0].pma_number
      How it applies
      The PMA number of this record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      26d4caf63fadb152906292f1d150372f894261149087da3580cac9fffdabba4d
      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-S005.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.

    2. Supports FDA premarket approval record P140017/S005: Melody Transcatheter Pulmonary Valve (PMA supplement S005, surgical bioprosthetic pulmonary valve) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · 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.

      Locator
      results[0].supplement_number
      How it applies
      The supplement number of this record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      26d4caf63fadb152906292f1d150372f894261149087da3580cac9fffdabba4d
      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-S005.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.

    3. Supports FDA premarket approval record P140017/S005: Melody Transcatheter Pulmonary Valve (PMA supplement S005, surgical bioprosthetic pulmonary valve) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · 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.

      Locator
      results[0].applicant
      How it applies
      The applicant, as FDA writes the name.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      26d4caf63fadb152906292f1d150372f894261149087da3580cac9fffdabba4d
      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-S005.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.

    4. Supports FDA premarket approval record P140017/S005: Melody Transcatheter Pulmonary Valve (PMA supplement S005, surgical bioprosthetic pulmonary valve) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · 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.

      Locator
      results[0].trade_name
      How it applies
      The trade name FDA gives this record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      26d4caf63fadb152906292f1d150372f894261149087da3580cac9fffdabba4d
      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-S005.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.

    5. Supports FDA premarket approval record P140017/S005: Melody Transcatheter Pulmonary Valve (PMA supplement S005, surgical bioprosthetic pulmonary valve) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · 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.

      Locator
      results[0].decision_date
      How it applies
      ISO date of the decision.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      26d4caf63fadb152906292f1d150372f894261149087da3580cac9fffdabba4d
      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-S005.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.

    6. Supports FDA premarket approval record P140017/S005: Melody Transcatheter Pulmonary Valve (PMA supplement S005, surgical bioprosthetic pulmonary valve) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · 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.

      Locator
      results[0].decision_code
      How it applies
      FDA decision code: APPR is an approval.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      26d4caf63fadb152906292f1d150372f894261149087da3580cac9fffdabba4d
      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-S005.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.

    7. Supports FDA premarket approval record P140017/S005: Melody Transcatheter Pulmonary Valve (PMA supplement S005, surgical bioprosthetic pulmonary valve) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · 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.

      Locator
      results[0].product_code
      How it applies
      FDA product code of this record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      26d4caf63fadb152906292f1d150372f894261149087da3580cac9fffdabba4d
      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-S005.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.

    8. Supports FDA premarket approval record P140017/S005: Melody Transcatheter Pulmonary Valve (PMA supplement S005, surgical bioprosthetic pulmonary valve) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · 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.

      Locator
      results[0].ao_statement
      How it applies
      FDA approval order statement: the approved indication, quoted in fragments.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      26d4caf63fadb152906292f1d150372f894261149087da3580cac9fffdabba4d
      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-S005.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.

    9. Background FDA premarket approval record P140017/S005: Melody Transcatheter Pulmonary Valve (PMA supplement S005, surgical bioprosthetic pulmonary valve) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · 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.

      Locator
      meta.disclaimer
      How it applies
      openFDA's own disclaimer about relying on its data.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      26d4caf63fadb152906292f1d150372f894261149087da3580cac9fffdabba4d
      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-S005.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.

    10. Supports FDA approval order for PMA supplement P140017/S005 (Melody valve, surgical bioprosthetic pulmonary valve)

      Regulator · U.S. Food and Drug Administration · Edition PDF fetched 2026-10-14; text read with pdftotext. The decision document of the FDA PMA database. · PMA: P140017/S005

      Locator
      page 1, Re: line
      How it applies
      The FDA approval order names the supplement as P140017/S005.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      776f44ac7dd6bfe857af1fdf4853dbbb3619744726a6501802b5a694804a42f6
      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.

Authorization

Regulatory decision: Melody transcatheter pulmonary valve

Applies to Mixed recipients
  • Children and adults with a clinical reason for intervention on a malfunctioning right ventricular outflow tract (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.
  • Not stated in the FDA record
  • United States (decision by the US Food and Drug Administration)
  • Pediatric and adult patients, as the order words it; no age bounds are given
  • Gestational age Not reported
  • Postnatal age Not reported
Follow-up Not applicable (regulatory decision)
Authority
U.S. Food and Drug Administration
Decision
Supplemental approval,
Pathway
PMA
Submission
P140017/S005
Product code
NPV
Jurisdictions
United States; note: United States
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.
Basis
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.

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.

A regulatory decision is separate from a guideline recommendation and from payment coverage.

Regulatory decision: Melody transcatheter pulmonary valve

Applies to Mixed recipients
  • 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.
  • Used as an addition to surgical care for these patients (order wording, paraphrased)
  • United States (decision by the US Food and Drug Administration)
  • Pediatric and adult patients, as the order words it; no age bounds are given
  • Gestational age Not reported
  • Postnatal age Not reported
Follow-up Not applicable (regulatory decision)
Authority
U.S. Food and Drug Administration
Decision
Approval,
Pathway
PMA
Submission
P140017
Product code
NPV
Jurisdictions
United States; note: United States
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).
Basis
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.

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.

A regulatory decision is separate from a guideline recommendation and from payment coverage.

Clinical links

Each link reports what one cited claim says about one population. "Evaluated for" means studied, not shown to work. These links do not show that anything is effective or right for you.

Record details

Record id
cardio:melody-transcatheter-pulmonary-valve
Content hash
ddcc874bd1377b59482dc3409db13225acc0d7624d44eacb60531d02e39d842b