PMA P240044S003

Device: Globe® Pulsed Field System
Applicant: Kardium, Inc.
PMA number: P240044
Supplement: S003
Product code: QZI
Decision date: 2026-01-06
Classification: Cardiovascular
Generic name: Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
Approval order statement: a manufacturing change to replace a Nd:YAG (Neodymium-doped Yttrium Aluminum Garnet) laser welder with a fiber laser welder for producing the coupling subassembly at the distal end of the catheter shaft

Current openFDA PMA Record#

Device: Globe® Pulsed Field System
Applicant: Kardium, Inc.
PMA number: P240044
Supplement: S003
Product code: QZI
Generic name: Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
Decision date: 2026-01-06
Decision code: OK30
Date received: 2025-12-08
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a manufacturing change to replace a Nd:YAG (Neodymium-doped Yttrium Aluminum Garnet) laser welder with a fiber laser welder for producing the coupling subassembly at the distal end of the catheter shaft