Approval for the harmony™ transcatheter pulmonary valve (tpv) system. This device is indicated for use in the management of pediatric and adult patients with severe pulmonary regurgitation (i. E. , severe pulmonary regurgitation as determined by echocardiography and/or pulmonary regurgitant fraction >= 30% as determined by cardiac magnetic resonance imaging) who have a native or surgically-repaired right ventricular outflow tract and are clinically indicated for surgical pulmonary valve replacement.
| Device | Harmony™ TPV System |
| Generic Name | Pulmonary Valve Prosthesis Percutaneously Delivered |
| Applicant | Medtronic, Inc. |
| Date Received | 2020-11-18 |
| Decision Date | 2021-03-26 |
| PMA | P200046 |
| Supplement | S |
| Product Code | NPV |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Medtronic, Inc. 3576 Unocal Place building A santa Rosa, CA 95403 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P200046 | | Original Filing |
| S013 |
2022-11-29 |
30-day Notice |
| S012 |
2022-10-31 |
30-day Notice |
| S011 |
2022-07-26 |
30-day Notice |
| S010 | | |
| S009 |
2022-05-16 |
30-day Notice |
| S008 |
2022-03-11 |
Normal 180 Day Track No User Fee |
| S007 |
2022-02-28 |
30-day Notice |
| S006 |
2021-12-02 |
30-day Notice |
| S005 |
2021-07-09 |
30-day Notice |
| S004 |
2021-07-01 |
30-day Notice |
| S003 | | |
| S002 |
2021-04-23 |
Special (immediate Track) |
| S001 |
2021-04-05 |
30-day Notice |
NIH GUDID Devices