PMA P240013S024

Device: Sphere-9 Catheter
Applicant: Medtronic, Inc.
PMA number: P240013
Supplement: S024
Product code: QZI
Decision date: 2026-04-21
Classification: Cardiovascular
Generic name: Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
Approval order statement: the addition of a new warning/precaution statement to the Sphere-9 catheter instructions for use to enhance safety

Current openFDA PMA Record#

Device: Sphere-9 Catheter
Applicant: Medtronic, Inc.
PMA number: P240013
Supplement: S024
Product code: QZI
Generic name: Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
Decision date: 2026-04-21
Decision code: APPR
Date received: 2026-03-24
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: the addition of a new warning/precaution statement to the Sphere-9 catheter instructions for use to enhance safety