PMA supplement
P240044 S001: Globe® Catheter and Globe® Pulsed Field System
FDA PMA supplement · Normal 180 Day Track No User Fee · Kardium, Inc.
Key facts
| Original PMA | P240044 |
|---|---|
| Supplement number | S001 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Postapproval Study Protocol |
| Trade name | Globe® Catheter and Globe® Pulsed Field System |
| Generic name | Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation |
| Applicant | Kardium, Inc. |
| Product code | QZI |
| Received date | Sep 29, 2025 |
| Decision date | Jun 23, 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: