PMA P240044S001

Device: Globe® Catheter and Globe® Pulsed Field System
Applicant: Kardium, Inc.
PMA number: P240044
Supplement: S001
Product code: QZI
Decision date: 2026-06-23
Classification: Cardiovascular
Generic name: Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
Approval order statement: approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P240044

Current openFDA PMA Record#

Device: Globe® Catheter and Globe® Pulsed Field System
Applicant: Kardium, Inc.
PMA number: P240044
Supplement: S001
Product code: QZI
Generic name: Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
Decision date: 2026-06-23
Decision code: APPR
Date received: 2025-09-29
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P240044