PMA P240044S005
- Device
- Globe® Catheter; Globe® Pulsed Field System
- Applicant
- Kardium, Inc.
- PMA number
- P240044
- Supplement
- S005
- Product code
- QZI
- Decision date
- 2026-06-12
- Classification
- Cardiovascular
- Generic name
- Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
- Approval order statement
- leak test process and equipment change
Current openFDA PMA Record#
- Device
- Globe® Catheter; Globe® Pulsed Field System
- Applicant
- Kardium, Inc.
- PMA number
- P240044
- Supplement
- S005
- Product code
- QZI
- Generic name
- Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
- Decision date
- 2026-06-12
- Decision code
- OK30
- Date received
- 2026-05-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- leak test process and equipment change