Approval for the melody transcatheter pulmonary valve, ensemble transcatheter valve delivery system, and ensemble ii transcatheter valve delivery system for expanding the indications to include patients with a dysfunctional surgical bioprosthetic pulmonary valve. The device is indicated for use in the management of pediatric and adult patients who have a clinical indication for intervention on a dysfunctional right ventricular outflow tract (rvot) conduit or surgical bioprosthetic pulmonary valve that has >= moderate regurgitation and/or a mean rvot gradient >= 35 mmhg.
| Device | MELODY TRANSCATHETER PULMONARY VALVE, ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM and ENSEMBLE II TRANSCATHETER VALVE D |
| Classification Name | Pulmonary Valve Prosthesis Percutaneously Delivered |
| Generic Name | Pulmonary Valve Prosthesis Percutaneously Delivered |
| Applicant | MEDTRONIC Inc. |
| Date Received | 2016-09-01 |
| Decision Date | 2017-02-24 |
| Notice Date | 2017-03-10 |
| PMA | P140017 |
| Supplement | S005 |
| Product Code | NPV |
| Docket Number | 17M-1227 |
| Advisory Committee | Cardiovascular |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |
| 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