Approval the melody transcatheter pulmonary valve (tpv) and the ensemble transcatheter valve deliverysystem. This device is indicated for use as an adjunct to surgery in the management of pediatric and adult patients with the following clinical conditions:1) existence of a full (circumferential) right ventricular outflow tract (rvot) conduit that was equal to or greater than 16 mm in diameter when originally implanted, and 2) dysfunctional rvot conduit with a clinical indication for intervention, and: a) regurgitation >= moderate regurgitation, and/or b) stenosis: mean rvot gradient >= mmhg.
| Device | MELODY TRANSCATHETER PULMONARY VALVE (TPV), ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM (DS) |
| Classification Name | Pulmonary Valve Prosthesis Percutaneously Delivered |
| Generic Name | Pulmonary Valve Prosthesis Percutaneously Delivered |
| Applicant | MEDTRONIC Inc. |
| Date Received | 2014-08-21 |
| Decision Date | 2015-01-27 |
| Notice Date | 2015-01-27 |
| PMA | P140017 |
| Supplement | S |
| Product Code | NPV |
| Docket Number | 15M-0266 |
| Advisory Committee | Cardiovascular |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | MEDTRONIC Inc. 8200 Coral Sea Street Ne mvs83 mounds View, MN 55112 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P140017 | | Original Filing |
| S023 |
2022-11-16 |
30-day Notice |
| S022 |
2022-07-20 |
30-day Notice |
| S021 |
2022-02-28 |
30-day Notice |
| S020 |
2022-01-27 |
30-day Notice |
| S019 |
2021-07-29 |
30-day Notice |
| S018 | | |
| S017 |
2019-10-01 |
30-day Notice |
| S016 | | |
| S015 |
2019-06-20 |
30-day Notice |
| S014 |
2018-11-13 |
Normal 180 Day Track No User Fee |
| S013 | | |
| S012 |
2018-10-01 |
30-day Notice |
| S011 |
2018-09-26 |
Real-time Process |
| S010 |
2017-12-01 |
30-day Notice |
| S009 | | |
| S008 |
2017-09-11 |
30-day Notice |
| S007 |
2017-04-19 |
30-day Notice |
| S006 |
2016-11-23 |
Normal 180 Day Track No User Fee |
| S005 |
2016-09-01 |
Panel Track |
| S004 |
2016-04-25 |
Normal 180 Day Track |
| S003 |
2016-04-08 |
30-day Notice |
| S002 |
2016-03-23 |
30-day Notice |
| S001 |
2015-06-17 |
30-day Notice |
NIH GUDID Devices