Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
Basic Information
- Device Name
- Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
- Trade Name
- Globe® Pulsed Field System
- PMA Number
- P240044
- Device Class
- FDA Class 3
- Product Code
- QZI
- Generic Name
- Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 27, 2025
- Date Received
- December 17, 2024
- Expedited Review
- N
Advisory Committee 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 stimulation of cardiac tissue.When used for pulsed field ablation, refer to the Instructions for Use of the compatible cardiac ablation catheter for the specific indications for use.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QZI | Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation | FDA class 3 | Unknown |