PMA P240013S016

Device: Sphere-9 Catheter and Affera Ablation System
Applicant: Medtronic, Inc.
PMA number: P240013
Supplement: S016
Product code: QZI
Decision date: 2025-09-19
Classification: Cardiovascular
Generic name: Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
Approval order statement: for the addition of new inspection tool and process for the Affera Tubing Set at Medtronic Billerica manufacturing facility

Current openFDA PMA Record#

Device: Sphere-9 Catheter and Affera Ablation System
Applicant: Medtronic, Inc.
PMA number: P240013
Supplement: S016
Product code: QZI
Generic name: Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
Decision date: 2025-09-19
Decision code: OK30
Date received: 2025-08-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: for the addition of new inspection tool and process for the Affera Tubing Set at Medtronic Billerica manufacturing facility