PMA P240044S002

Device: Globe Catheter (601-01000)
Applicant: Kardium, Inc.
PMA number: P240044
Supplement: S002
Product code: QZI
Decision date: 2026-02-18
Classification: Cardiovascular
Generic name: Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
Approval order statement: request approval for an update to the Globe Catheter instructions for use (IFU) to provide simplified catheter preparation and air management procedures

Current openFDA PMA Record#

Device: Globe Catheter (601-01000)
Applicant: Kardium, Inc.
PMA number: P240044
Supplement: S002
Product code: QZI
Generic name: Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
Decision date: 2026-02-18
Decision code: APPR
Date received: 2025-11-17
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: request approval for an update to the Globe Catheter instructions for use (IFU) to provide simplified catheter preparation and air management procedures