PMA
P220026: Symplicity Spyral™ Renal Denervation System
FDA PMA · Ablation catheter, renal denervation · Medtronic, Inc.
Key facts
| PMA number | P220026 |
|---|---|
| Trade name | Symplicity Spyral™ Renal Denervation System |
| Generic name | Ablation catheter, renal denervation |
| Applicant | Medtronic, Inc. |
| Owner/operator | Medtronic, Inc. |
| Product code | QYI |
| Approval date | Nov 17, 2023 |
| Docket number | 23M-5472 |
| Notice date | Dec 15, 2023 |
| Establishment registration | 2953200 |
| FEI number | 3001452571 |
At a glance
- 10–99 Supplements
- Sep 10, 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- No Withdrawn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: