PMA P240013S028

Device: Sphere-9 Catheter™ and Affera™ Ablation System
Applicant: Medtronic, Inc.
PMA number: P240013
Supplement: S028
Product code: QZI
Decision date: 2026-10-06
Classification: Cardiovascular
Generic name: Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
Approval order statement: Approval for modifications to the packaging and labeling of the Sphere-9 Catheter and a Predetermined Change Control Plan to extend the shelf life of the device from 13 months to 25 months.

Current openFDA PMA Record#

Device: Sphere-9 Catheter™ and Affera™ Ablation System
Applicant: Medtronic, Inc.
PMA number: P240013
Supplement: S028
Product code: QZI
Generic name: Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
Decision date: 2026-10-06
Decision code: APPR
Date received: 2026-07-08
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for modifications to the packaging and labeling of the Sphere-9 Catheter and a Predetermined Change Control Plan to extend the shelf life of the device from 13 months to 25 months.