PMA
P240013: Sphere-9 Catheter and Affera Ablation System
FDA PMA · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation · Medtronic, Inc.
Key facts
| PMA number | P240013 |
|---|---|
| Trade name | Sphere-9 Catheter and Affera Ablation System |
| Generic name | Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation |
| Applicant | Medtronic, Inc. |
| Owner/operator | Medtronic, Inc. |
| Product code | QZI |
| Approval date | Oct 24, 2024 |
| Establishment registration | 2182208 |
| FEI number | 2182208 |
At a glance
- 10–99 Supplements
- Oct 9, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 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: