PMA supplement
P200046 S045: Harmony Transcatheter Pulmonary Valve
FDA PMA supplement · 135 Review Track For 30-Day Notice · Medtronic, Inc.
Key facts
| Original PMA | P200046 |
|---|---|
| Supplement number | S045 |
| Supplement type | 135 Review Track For 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Harmony Transcatheter Pulmonary Valve |
| Generic name | Pulmonary valve prosthesis percutaneously delivered |
| Applicant | Medtronic, Inc. |
| Product code | NPV |
| Received date | Sep 29, 2025 |
| Decision date | Feb 12, 2026 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: