# Melody transcatheter pulmonary valve

Product · id `cardio:melody-transcatheter-pulmonary-valve` · Cardiovascular Atlas · release `5dcd9b263fe17744` (public)

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Also called: Melody TPV; Melody valve

Browse, organ or system: Heart  
Browse, condition area: Valve and congenital heart disease  

## In plain language

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.

## 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.

## Claims, with the population each applies to

## 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)

### 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.

- Category: Regulatory
- Evidence stage: Evidence stage not applicable
- Certainty: Certainty not assessed
- Applies to: 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)
- 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
- Sources:
  1. Supports: FDA premarket approval record P140017: Melody Transcatheter Pulmonary Valve and Ensemble delivery system (original PMA approval) (openFDA record) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P140017&sort=decision_date:asc&limit=1>
     Locator: results\[0\].pma\_number. Retrieved 2026-10-14T18:21:12Z. Source state: Current. Snapshot hash: 56ea2833b16f4a7a4c5db1259df3bd54c1965e7e1d21a50b52b3584fc3311a9b.
     How it applies: The PMA number of this record.
  2. Supports: FDA premarket approval record P140017: Melody Transcatheter Pulmonary Valve and Ensemble delivery system (original PMA approval) (openFDA record) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P140017&sort=decision_date:asc&limit=1>
     Locator: results\[0\].applicant. Retrieved 2026-10-14T18:21:12Z. Source state: Current. Snapshot hash: 56ea2833b16f4a7a4c5db1259df3bd54c1965e7e1d21a50b52b3584fc3311a9b.
     How it applies: The applicant, as FDA writes the name.
  3. Supports: FDA premarket approval record P140017: Melody Transcatheter Pulmonary Valve and Ensemble delivery system (original PMA approval) (openFDA record) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P140017&sort=decision_date:asc&limit=1>
     Locator: results\[0\].trade\_name. Retrieved 2026-10-14T18:21:12Z. Source state: Current. Snapshot hash: 56ea2833b16f4a7a4c5db1259df3bd54c1965e7e1d21a50b52b3584fc3311a9b.
     How it applies: The trade name FDA gives this record.
  4. Supports: FDA premarket approval record P140017: Melody Transcatheter Pulmonary Valve and Ensemble delivery system (original PMA approval) (openFDA record) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P140017&sort=decision_date:asc&limit=1>
     Locator: results\[0\].decision\_date. Retrieved 2026-10-14T18:21:12Z. Source state: Current. Snapshot hash: 56ea2833b16f4a7a4c5db1259df3bd54c1965e7e1d21a50b52b3584fc3311a9b.
     How it applies: ISO date of the decision.
  5. Supports: FDA premarket approval record P140017: Melody Transcatheter Pulmonary Valve and Ensemble delivery system (original PMA approval) (openFDA record) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P140017&sort=decision_date:asc&limit=1>
     Locator: results\[0\].decision\_code. Retrieved 2026-10-14T18:21:12Z. Source state: Current. Snapshot hash: 56ea2833b16f4a7a4c5db1259df3bd54c1965e7e1d21a50b52b3584fc3311a9b.
     How it applies: FDA decision code: APPR is an approval.
  6. Supports: FDA premarket approval record P140017: Melody Transcatheter Pulmonary Valve and Ensemble delivery system (original PMA approval) (openFDA record) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P140017&sort=decision_date:asc&limit=1>
     Locator: results\[0\].product\_code. Retrieved 2026-10-14T18:21:12Z. Source state: Current. Snapshot hash: 56ea2833b16f4a7a4c5db1259df3bd54c1965e7e1d21a50b52b3584fc3311a9b.
     How it applies: FDA product code of this record.
  7. Supports: FDA premarket approval record P140017: Melody Transcatheter Pulmonary Valve and Ensemble delivery system (original PMA approval) (openFDA record) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P140017&sort=decision_date:asc&limit=1>
     Locator: results\[0\].ao\_statement. Retrieved 2026-10-14T18:21:12Z. Source state: Current. Snapshot hash: 56ea2833b16f4a7a4c5db1259df3bd54c1965e7e1d21a50b52b3584fc3311a9b.
     How it applies: FDA approval order statement: the approved indication, quoted in fragments.
  8. Background: FDA premarket approval record P140017: Melody Transcatheter Pulmonary Valve and Ensemble delivery system (original PMA approval) (openFDA record) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P140017&sort=decision_date:asc&limit=1>
     Locator: meta.disclaimer. Retrieved 2026-10-14T18:21:12Z. Source state: Current. Snapshot hash: 56ea2833b16f4a7a4c5db1259df3bd54c1965e7e1d21a50b52b3584fc3311a9b.
     How it applies: openFDA's own disclaimer about relying on its data.
  9. Supports: FDA summary of safety and effectiveness data for PMA P140017 (Melody valve) (Regulator, edition PDF fetched 2026-10-14; text read with pdftotext. The decision document of the FDA PMA database.) <https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140017B.pdf>
     Locator: Section II, Indications for use. Retrieved 2026-10-14T19:20:13Z. Source state: Current. Snapshot hash: 81d4e9efac04389bb41e8f2691a6318afebe8381e3f64f06e879c9de8dd62cd2.
     How it applies: The summary of safety and effectiveness prints the regurgitation and mean gradient criteria, including 35 mmHg.

### 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.

- Category: Description
- Evidence stage: Evidence stage not applicable
- Certainty: Certainty not assessed
- Applies to: 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)
- 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
- Sources:
  1. Supports: FDA premarket approval record P140017: Melody Transcatheter Pulmonary Valve and Ensemble delivery system (original PMA approval) (openFDA record) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P140017&sort=decision_date:asc&limit=1>
     Locator: results\[0\].ao\_statement. Retrieved 2026-10-14T18:21:12Z. Source state: Current. Snapshot hash: 56ea2833b16f4a7a4c5db1259df3bd54c1965e7e1d21a50b52b3584fc3311a9b.
     How it applies: The original approval order statement: the approved indication.
  2. Supports: FDA summary of safety and effectiveness data for PMA P140017 (Melody valve) (Regulator, edition PDF fetched 2026-10-14; text read with pdftotext. The decision document of the FDA PMA database.) <https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140017B.pdf>
     Locator: Section II, Indications for use. Retrieved 2026-10-14T19:20:13Z. Source state: Current. Snapshot hash: 81d4e9efac04389bb41e8f2691a6318afebe8381e3f64f06e879c9de8dd62cd2.
     How it applies: The summary of safety and effectiveness prints the regurgitation and mean gradient criteria, including 35 mmHg.

## 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)

### 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.

- Category: Regulatory
- Evidence stage: Evidence stage not applicable
- Certainty: Certainty not assessed
- Applies to: 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)
- 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
- Sources:
  1. Supports: FDA premarket approval record P140017/S005: Melody Transcatheter Pulmonary Valve (PMA supplement S005, surgical bioprosthetic pulmonary valve) (openFDA record) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P140017+AND+supplement_number:S005&limit=1>
     Locator: results\[0\].pma\_number. Retrieved 2026-10-14T18:21:19Z. Source state: Current. Snapshot hash: 26d4caf63fadb152906292f1d150372f894261149087da3580cac9fffdabba4d.
     How it applies: The PMA number of this record.
  2. Supports: FDA premarket approval record P140017/S005: Melody Transcatheter Pulmonary Valve (PMA supplement S005, surgical bioprosthetic pulmonary valve) (openFDA record) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P140017+AND+supplement_number:S005&limit=1>
     Locator: results\[0\].supplement\_number. Retrieved 2026-10-14T18:21:19Z. Source state: Current. Snapshot hash: 26d4caf63fadb152906292f1d150372f894261149087da3580cac9fffdabba4d.
     How it applies: The supplement number of this record.
  3. Supports: FDA premarket approval record P140017/S005: Melody Transcatheter Pulmonary Valve (PMA supplement S005, surgical bioprosthetic pulmonary valve) (openFDA record) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P140017+AND+supplement_number:S005&limit=1>
     Locator: results\[0\].applicant. Retrieved 2026-10-14T18:21:19Z. Source state: Current. Snapshot hash: 26d4caf63fadb152906292f1d150372f894261149087da3580cac9fffdabba4d.
     How it applies: The applicant, as FDA writes the name.
  4. Supports: FDA premarket approval record P140017/S005: Melody Transcatheter Pulmonary Valve (PMA supplement S005, surgical bioprosthetic pulmonary valve) (openFDA record) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P140017+AND+supplement_number:S005&limit=1>
     Locator: results\[0\].trade\_name. Retrieved 2026-10-14T18:21:19Z. Source state: Current. Snapshot hash: 26d4caf63fadb152906292f1d150372f894261149087da3580cac9fffdabba4d.
     How it applies: The trade name FDA gives this record.
  5. Supports: FDA premarket approval record P140017/S005: Melody Transcatheter Pulmonary Valve (PMA supplement S005, surgical bioprosthetic pulmonary valve) (openFDA record) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P140017+AND+supplement_number:S005&limit=1>
     Locator: results\[0\].decision\_date. Retrieved 2026-10-14T18:21:19Z. Source state: Current. Snapshot hash: 26d4caf63fadb152906292f1d150372f894261149087da3580cac9fffdabba4d.
     How it applies: ISO date of the decision.
  6. Supports: FDA premarket approval record P140017/S005: Melody Transcatheter Pulmonary Valve (PMA supplement S005, surgical bioprosthetic pulmonary valve) (openFDA record) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P140017+AND+supplement_number:S005&limit=1>
     Locator: results\[0\].decision\_code. Retrieved 2026-10-14T18:21:19Z. Source state: Current. Snapshot hash: 26d4caf63fadb152906292f1d150372f894261149087da3580cac9fffdabba4d.
     How it applies: FDA decision code: APPR is an approval.
  7. Supports: FDA premarket approval record P140017/S005: Melody Transcatheter Pulmonary Valve (PMA supplement S005, surgical bioprosthetic pulmonary valve) (openFDA record) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P140017+AND+supplement_number:S005&limit=1>
     Locator: results\[0\].product\_code. Retrieved 2026-10-14T18:21:19Z. Source state: Current. Snapshot hash: 26d4caf63fadb152906292f1d150372f894261149087da3580cac9fffdabba4d.
     How it applies: FDA product code of this record.
  8. Supports: FDA premarket approval record P140017/S005: Melody Transcatheter Pulmonary Valve (PMA supplement S005, surgical bioprosthetic pulmonary valve) (openFDA record) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P140017+AND+supplement_number:S005&limit=1>
     Locator: results\[0\].ao\_statement. Retrieved 2026-10-14T18:21:19Z. Source state: Current. Snapshot hash: 26d4caf63fadb152906292f1d150372f894261149087da3580cac9fffdabba4d.
     How it applies: FDA approval order statement: the approved indication, quoted in fragments.
  9. Background: FDA premarket approval record P140017/S005: Melody Transcatheter Pulmonary Valve (PMA supplement S005, surgical bioprosthetic pulmonary valve) (openFDA record) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P140017+AND+supplement_number:S005&limit=1>
     Locator: meta.disclaimer. Retrieved 2026-10-14T18:21:19Z. Source state: Current. Snapshot hash: 26d4caf63fadb152906292f1d150372f894261149087da3580cac9fffdabba4d.
     How it applies: openFDA's own disclaimer about relying on its data.
  10. Supports: FDA approval order for PMA supplement P140017/S005 (Melody valve, surgical bioprosthetic pulmonary valve) (Regulator, edition PDF fetched 2026-10-14; text read with pdftotext. The decision document of the FDA PMA database.) <https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140017S005A.pdf>
     Locator: page 1, Re: line. Retrieved 2026-10-14T19:20:13Z. Source state: Current. Snapshot hash: 776f44ac7dd6bfe857af1fdf4853dbbb3619744726a6501802b5a694804a42f6.
     How it applies: The FDA approval order names the supplement as P140017/S005.

## Guidance, authorization and access

### Regulatory decision `cardio:regdec-fda-p140017-s005`

- Product: Melody transcatheter pulmonary valve (`cardio:melody-transcatheter-pulmonary-valve`)
- Authority: U.S. Food and Drug Administration (`core:fda`)
- Decision: Supplemental approval, 2017-02-24
- Product version: Melody Transcatheter Pulmonary Valve with the Ensemble and Ensemble II delivery systems (PMA supplement S005)
- Pathway: PMA
- Submission: P140017/S005
- Product code: NPV
- 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.
- Jurisdictions: United States; note: United States
- Applies to: 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)
- Basis: claim `cardio:claim-fda-p140017-s005-bioprosthetic-valve`

### Regulatory decision `cardio:regdec-fda-p140017`

- Product: Melody transcatheter pulmonary valve (`cardio:melody-transcatheter-pulmonary-valve`)
- Authority: U.S. Food and Drug Administration (`core:fda`)
- Decision: Approval, 2015-01-27
- Product version: Melody Transcatheter Pulmonary Valve (TPV) and Ensemble Transcatheter Valve Delivery System (original approval)
- Pathway: PMA
- Submission: P140017
- Product code: NPV
- 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).
- Jurisdictions: United States; note: United States
- Applies to: 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)
- Basis: claim `cardio:claim-fda-p140017-approval`

## Connected pages

- Registered as a manufacturing establishment (Medtronic Heart Valves Division) for the P140017 devices in the current openFDA listing; the listing gives Medtronic, Inc. as its owner or operator, and Medtronic, Inc. is also the applicant on PMA P140017: Medtronic (`cardio:medtronic`)
- FDA approval scope only: a catheter valve for a dysfunctional right ventricular outflow tract conduit of 16 mm or more when implanted, with a clinical indication for intervention and at least moderate regurgitation and/or a mean gradient of 35 mmHg or more, in pediatric and adult patients; the 2017 widening has its own decision record; no trial results are recorded: Adult congenital heart disease (`cardio:adult-congenital-heart-disease`) [a claim, not a settled fact; see claim `cardio:claim-melody-approved-scope` and its context]
- Filed under this front: Procedures and surgery (`cardio:front-procedures-and-surgery`)

## Provenance

Content hash: e713ba1bf995b2d77b9daaa4a169e3823c6c54ef900e9191c6165fd30b2898d5
Last substantive edit: 2026-10-15
Evidence last checked: 2026-10-14