Globe® Pulsed Field System
FDA premarket approval P240044 · decided 2025-08-27
Approval details
- 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.
- Date received
- 2024-12-17
- Decision date
- 2025-08-27
- Days to decision
- 253 days
- Decision code
- APPR
- Product code
- QZI
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Burnaby
- Statement
- approval for the Globe® Pulsed Field System. This device is indicated for: The Globe® Catheter is indicated for anatomical and electrophysiological mapping and stimulation of cardiac tissue, and for the delivery of ablation energy for the treatment of drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, when used in conjunction with the Globe Pulsed Field System. The Globe® PF System is indicated for catheter-based cardiac anatomical and electrophysiological mapping and stimul
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Globe® Pulsed Field System (K250747) | Kardium, Inc. | 2025-06-25 |
| Globe Introducer (601-01001) (K250529) | Kardium, Inc. | 2025-06-03 |