PMA
P200046: Harmony™ TPV System
FDA PMA · Pulmonary valve prosthesis percutaneously delivered · Medtronic, Inc.
Key facts
| PMA number | P200046 |
|---|---|
| Trade name | Harmony™ TPV System |
| Generic name | Pulmonary valve prosthesis percutaneously delivered |
| Applicant | Medtronic, Inc. |
| Owner/operator | Medtronic, Inc. |
| Product code | NPV |
| Approval date | Mar 26, 2021 |
| Docket number | 21M-0354 |
| Notice date | Apr 12, 2021 |
| Establishment registration | 3001504994 |
| FEI number | 3001504994 |
At a glance
- 10–99 Supplements
- Sep 30, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: