PMA P240044S008

Device: Globe® Pulsed Field System; Globe Catheter
Applicant: Kardium, Inc.
PMA number: P240044
Supplement: S008
Product code: QZI
Decision date: 2026-10-23
Classification: Cardiovascular
Generic name: Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
Approval order statement: modification to the sterilization cycle parameters and use of a larger maximum sterilization load

Current openFDA PMA Record#

Device: Globe® Pulsed Field System; Globe Catheter
Applicant: Kardium, Inc.
PMA number: P240044
Supplement: S008
Product code: QZI
Generic name: Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
Decision date: 2026-10-23
Decision code: OK30
Date received: 2026-09-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: modification to the sterilization cycle parameters and use of a larger maximum sterilization load