PMA
P240044: Globe® Pulsed Field System
FDA PMA · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation · Kardium, Inc.
Key facts
| PMA number | P240044 |
|---|---|
| Trade name | Globe® Pulsed Field System |
| Generic name | Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation |
| Applicant | Kardium, Inc. |
| Owner/operator | Kardium Inc. |
| Product code | QZI |
| Approval date | Aug 27, 2025 |
| Establishment registration | 3007603855 |
| FEI number | 3007603855 |
At a glance
- 1–9 Supplements
- Aug 20, 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- No Withdrawn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: